Input: [ID] 129 [Entry Date] 04/18/2011 at 11:32:15 AM [Affiliation] Self [Comments]

Output: Comment 1: ASPET urges OLAW not to adopt the 2011 edition of the Guide. Its deviation from the 1996 Guide will result in a significant increase in regulatory and paperwork burden and expense without benefit to animal welfare. ASPET supports the comments of NABR that were submitted to Francis Collins, Director of NIH. Our comments will focus on the newly added section "Use of Non-Pharmaceutical Grade Chemicals [NPC] and Other Substances," which adds new policy to the Guide that is unwarranted with respect to animal welfare or good research practice. Albeit well intended, this policy is not well informed regarding the conduct of research that uses drugs in laboratory animals. One problem with the new guidance on NPC is that the term "pharmaceutical grade" is not defined, nor does an accepted definition exist. An indication of its intended meaning is Guide citation of USDA/APHIS Policy 3, which covers "sedatives, analgesics, or anesthetics" used to prevent pain/distress with regulated species. Its use of "non-pharmaceutical grade" refers to medications not prepared for clinical use. The Guide extends Policy 3 terminology to all vertebrates and all chemicals used in research. The implication is that all solutions prepared by a researcher are considered of inferior quality and that clinical solutions are ideal for research, neither of which is accurate. Specifically, ASPET notes the following with respect to the four sentences on NPC in the Guide: (1) "The use of pharmaceutical grade chemicals. . .ensures that toxic or unwanted side effects are not introduced into studies. . . ." The use of commercially prepared solutions does not ensure this. There are many examples of commercial solutions being recalled. Mass manufacture of pharmaceutical grade drugs amplifies any error. (2) "They should therefore be used, when available, for all animal-related procedures. . ." The assertion that clinical formulations are superior for all-animal-related procedures is neither logical nor supported by scientific evidence. Laboratory-prepared formulations have been the norm in research for the last century. There is no evidence that research or animal welfare would be improved by changing this research practice. The way in which drugs are formulated for clinical use make them poor choices for research. For example, dose manipulations are essential to research. Unlike clinical use, volume of drug delivery needs to be held constant. The single concentrations of solutions sold commercially inevitably need to be diluted to manipulate dose. The assumed benefit of using a commercial solution are lost. Another element of good research is comparison of the effects of the drug with that of vehicle alone. Vehicles of commercial solutions cannot easily be duplicated. (3) "The use of [NPCs] should be described and justified in the animal use protocol and be approved by the IACUC. . . for example, the use of [NPC] may be necessary to meet the goals of a project or when a veterinary or human pharmaceutical-grade product is unavailable." The wording implies the need for an NPC is unusual. In reality, it is the rule. The vast majority of animal research involves compounds that are not used clinically. New chemical entities are key to advances in science and public health. Collaborations with academic, government, or industry chemists are common; many high purity compounds are available from highly regarded commercial sources. Drug supply programs at NIH make controlled substances and other compounds not formulated for use in humans available to researchers without cost, as do biotechnical and pharmaceutical firms. To require that each use of an "NPC" be justified in writing and reviewed and approved by an IACUC places an unwarranted paperwork burden on researchers and on the IACUC. (4) "Consideration should be given to the grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics of the chemical or substance to be administered, as well as animal welfare and scientific issues relating to its use (NIH 2008)." These considerations are applicable to veterinary care, but are of more variable relevance to research. A part of each research project that uses chemical compounds necessarily involves determining details of their use that will assure the meaningful characterization of the effects of the compound. ASPET suggests that requiring these to be spelled out in advance, and reviewed and approved by the IACUC singles out pharmacology research for micromanagement--a function that has not been the traditional goal or value of the Guide. Note also that the citation is to an intramural NIH guideline, which defines "pharmaceutical grade" differently than does USDA/APHIS Policy 3. In summary, the newly added Guide requirement to use drugs formulated for clinical use in research animals is not realistic. For the few situations in which such a drug might be available, the practical needs of research make them unsuitable, and the cost, compared to one suited for laboratory can be significant (e.g., up to 10-fold). To require NIH's drug supply programs to substitute clinical-use solutions for all those it currently provides via its drug supply programs would be an expense that does not justify use of scarce research dollars. Should OLAW adopt the 2011 Guide, ASPET urges that it consult NIH Institute Directors regarding the wisdom of including the NPC section as PHS Policy

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 130 [Entry Date] 04/18/2011 at 11:40:10 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 131 [Entry Date] 04/18/2011 at 11:42:52 AM [Affiliation] Self [Comments]

Output: Comment 1: I have a several concerns regarding the proposed new (8th) edition of the Guide, but my comments below are specifically limited to two of the guidelines on Food and Fluid Regulation (pp 30-31). 1. The proposed Guide states that "The objective… …should be to use the least [food and/or fluid] restriction necessary to achieve the scientific objective while maintaining animal well-being" (pp. 30-31). This view runs counter to both good science and established animal husbandry and care practice. First, as noted in the publications cited in this section of the Guide, there is little or no evidence that moderate restriction protocols (e.g., in rodents, to 80-85% of free feeding weight for food restriction, or 24 hours for fluid restriction) have any adverse consequences under most circumstances. Second, some degree of food restriction or limitation is common practice for most laboratory species (e.g. – rabbits, dogs, primates), not to mention for pets and zoo animals. Indeed, the absence of any sort of restriction seems only to be usual practice with laboratory mice and rats, for which free feeding seems to have developed as a matter of convenience for husbandry staff. Third, there is ample scientific evidence across multiple species that long-term food restriction (e.g. – to 80-85% of free-feeding weight in rodents) confers significant health benefits, including longer life-span, fewer age-related diseases, and fewer neoplasms. In fact, even the Guide itself (Chapter 3, p. 67) describes the health benefits (even in mice and rats) of moderate caloric restriction. Hence, based upon the work cited in the Guide itself, there appears to be no scientific evidence for (and ample scientific evidence against) the apparent assumption that any degree of restriction is negative. 2. The proposed Guide states that "In the case of conditioned-response research protocols, use of a highly preferred food or fluid as positive reinforcement, instead of restriction, is recommended" (pp. 30-31). This recommendation, although admirable in theory, runs counter to decades of scientific research and practice, which show that animals will rarely if ever learn and perform food- or fluid-motivated behaviors in the absence of some degree of restriction. This point is made strongly in two of the publications cited in this section of the Guide (Toth and Gardiner 2000; Rowland 2007). More practically, however, one could infer the fact that highly palatable foods or fluids are not effective motivational tools for behavioral studies in the absence of restriction simply from the fact that they are not used. Food/fluid restriction procedures are time-consuming and add additional administrative burdens, both of which drive up the costs of conducting research. If it were at all possible to avoid restriction procedures when conducting behavioral experiments in animals, then they would be avoided.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 132 [Entry Date] 04/18/2011 at 11:48:54 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 133 [Entry Date] 04/18/2011 at 11:52:46 AM [Affiliation] Self [Comments]

Output: Comment 1: NO. This is an emphatic NO. The new guide was originally supposed to be an "update" of the 1996 Guide--however the final product is 2x as long and contains a great deal of NEW "policy" that has not been properly vetted and is not supported by data. Compliance with these NEW "policy" statements undoubtedly will greatly increase the expense of conducting public health research to both institutions (e.g., new requirements for cage size) and investigators (e.g., new constraints on the use of experimental drugs) without need. The scientific data justifying these expensive changes are non-existent. The policy changes laid out in the new Guide, if implemented, represent regulatory mischief that results in no real enhancement of animal welfare. Adherence to the proposed 2011 Guide also will require large increase in paperwork (e.g., all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new Guide may also negate the opportunity to diminish the burden resulting from previous over-reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies will unduly increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. Some specific examples of recommendations that are unwarranted by data include: constraints on multiple procedures in experimental subjects, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" that can be given to subjects under study, and specific guidance on "post-approval" monitoring (e.g., observation of procedures). Finally, the new "Guide" requires an increased level of intra and post-operative surgical procedures--again, without data indicating need. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. Those data alone should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 134 [Entry Date] 04/18/2011 at 12:06:23 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 135 [Entry Date] 04/18/2011 at 12:18:59 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 136 [Entry Date] 04/18/2011 at 12:55:35 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 137 [Entry Date] 04/18/2011 at 12:59:57 PM [Affiliation] Self [Comments]

Output: Comment 1: The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 138 [Entry Date] 04/18/2011 at 01:40:10 PM [Affiliation] Self [Comments]

Output: Comment 1: I have been a veterinarian for 25 years working in private practice, then becoming an emergency medicine clinician for 16 years and have now worked in laboratory medicine the past 7 years. I teach human handling classes, provide required veterinary reviews of animal use protocols for both our institution as well as for another institution and serve as a clinical veterinarian. During my time as a laboratory animal veterinarian, I feel I have been effective in improving researchers understanding that research animals are a small living environment rather than a petri-dish with legs. I have helped many understand that improvements in techniques, though some may take more time, are better for the animals well being or reduces their stress exposure and hence improve research efforts. I am a fervent believer in the application of the scientific method in that all practical efforts should be made to remove as many variables or subjective data related to determine accurate data related to the aims of the experiment. However I do not see or appreciate such scientific justifications for the proposed changes in the new GUIDE. There is apparent lack of logic in some of the changes proposed, such as the requirement in rabbit cage height. As written, thousands of cages would no longer be useable per the new requirement. If a scientific basis is provided to make such a change in additional height, it would be logical to set a weight value (or rump to head length measurement) to determine when larger cages are required to be used, just a mass value is assigned to caging for use with NHPs. This would allow many the current cages (most purchased with taxpayers dollars) to be used for rabbits smaller than the cut off weight for new height requirement. It is wonderful to consider changes for the well being of animals, but we should not do them based on personal opinions alone but rather based on scientifically proven benefit to animals health or well being ( given as they are used scientifically, this would be logical). If such changes as proposed in the Current Draft, are finally approved by PHS, a logical grace period should be given 1) Based on the current economic environment of our nation there are no magic dollars to make required changes rapidly for many institutions unless PHS plans to provide needed grants. 2) Changes may require more than just acquisition of 'new caging' but include major physical plant changes, new housing rooms be built, HVAC upgrades to meet human and animal health exposure requirements, none of which can be accomplished rapidly or often requireing over a year to implement. If the panel that reviewed/ updated the new GUIDE can provide me with scientific data for the proposed changes, I would be happy to re-consider my stated views, otherwise let us not burden the taxpayer with changes that only make people 'feel better' as to the use of animals but provide no scientific benefit to the health or well being of those animals. Comment 2: As stated in my response to the prior section, many faclilities may require physical plant upgrades not just the purchase of new cages, hence if the draft of the NEW GUIDE is approved, I would suggest 2 year grace period before full implementation of the 'New GUIDES" requirements would be more logical given the current economic status of our country, unless PHS if willing to provide needed funding for any such neeeded facilities changes.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 139 [Entry Date] 04/18/2011 at 01:56:35 PM [Affiliation] Self [Comments]

Output: Comment 1: The NIH should not adopt the 8th edition of the Guide for the Care and Use of Laboratory Animals. The new regulations are burdensome for investigators and add little to the welfare of laboratory animals. The previous edition is adequate. Comment 2: See above comment.8170

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 140 [Entry Date] 04/18/2011 at 02:31:48 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 141 [Entry Date] 04/18/2011 at 02:38:55 PM [Affiliation] Self [Organization Name] University of California Irvine [Organization City and State] Irvine, CA [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 142 [Entry Date] 04/18/2011 at 02:42:48 PM [Affiliation] Self [Organization City and State] Winston-Salem, NC [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 143 [Entry Date] 04/18/2011 at 02:54:15 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 144 [Entry Date] 04/18/2011 at 03:02:18 PM [Affiliation] Self [Comments]

Output: Comment 1: This letter is submitted in response to the National Institutes of Health's solicitation of comments concerning the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). While I support the use of the Guide as a document that promotes animal welfare while supporting the needs of the research community, I cannot support adoption of the Guide in its present form. The emphasis on performance based standards and professional judgment in much of the text is commendable, but I am concerned about new recommendations for rodent housing that 1) are not supported by scientific literature, 2) as presented appear to be fixed engineering standards, and 3) will have a significant financial impact on animal care and use programs that will be passed on to the investigators thereby limiting their ability to successfully complete research aims. During pre-publication review, the American College of Laboratory Animal Medicine commented that minimal cage size requirements for rodents presented in Table 3.2 of the Guide appear to be adopted from Annex II of the European Directive with a modification. In the European Directive an analogous table stipulates that mouse cages should provide 330 cm2 for each breeding pair with the qualification that a breeding pair is a "...monogamous pair (inbred/outbred) or trio (inbred)." Table 3.2 in the Guide however, calls for a minimum of 330 cm2 for a female with a liter plus 96.7 cm2 for each additional average sized adult mouse. Consequently, standard mouse cages used by facilities throughout the country are not large enough to house some rodent pairs (male and female) and all trios (one male, 2 females) typically maintained together for breeding purposes. In the final version an asterisk was added to Table 3.2 with the related note: "* The interpretation of this table should take into consideration the performance indices described in the text beginning on page 55." However, this edit lacks the desired clarity since the discussion on performance standards that begin on page 55 continues to page 56 with a statement that reads, "space recommendations presented here….should be considered the minimum for animals housed under conditions commonly found in laboratory animal facilities". Moreover, one "frequently asked question" published on OLAW's website leads us to believe that the flexibility of institutions to use performance based standards to develop and implement a policy to house mice in configurations that result in less space than stipulated in the Guide is limited. The text of that posting appears below: May the IACUC approve deviations from the Guide for rodent (mice and rats) cage density? - OLAW supports the Guide's approach to applying performance standards to achieve specified outcomes, and expects institutions to use the Guide's engineering standards as a baseline. The Guide clearly states that the need for adjustments to the recommendations for primary space enclosures should be made at the institutional level by the Institutional Animal Care and Use Committee (IACUC) and should be based on performance outcomes. The Guide further identifies examples of performance indices to assess adequacy of housing, including health, reproduction, growth, behavior, activity, and use of space (Guide, pages 25-26). IACUC determinations of the need for adjustments in the space recommendations should be based on veterinary considerations or scientific justification relative to the nature of the protocol and its requirements. Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable. IACUC approved deviations from the Guide must be clearly documented and reflect the scientific or veterinary justification relevant to the action. It is important to note the authors provide no scientific justification for the increased cage size requirement and in fact describe as insufficient the information that's available to delineate space and housing needs of laboratory species. By implementing the standards in the new Guide PHS-assured institutions will be forced to purchase additional cages or larger cages for breeding pairs and trios, which may required the purchase of additional racks, and in many instances, the construction of additional rooms to accommodate the increases. Alternatively, researchers would be forced to scale back breeding populations of inbred mice, thereby limiting research. Either way, NIH funded research facilities will incur substantial costs that could easily run into the hundreds of millions of dollars. It is with great reluctance that I have decided that I cannot support the adoption of the Guide. If the Guide were adopted by the NIH, PHS-assured institutions would be forced to spend hundreds of millions of dollars to fully comply. These costs would be in large part be passed on to the investigators in the form of increased charges which would negatively impact their ability to maintain their currently level of productivity. Increasing the cost of doing animal based research without solid scientific evidence that such increases are needed is not consistent with the NIH's goal "to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research."

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 145 [Entry Date] 04/18/2011 at 03:15:50 PM [Affiliation] Self [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore MD [Comments]

Output: Comment 1: I am writing regarding the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals with specific reference to housing requirements for mice. I am fully supportive of maintaining animal health and well-being in a laboratory environment. However, it is not evident that the new guidelines that specify15 sq. in. of floor space per mouse have any basis in science or will in fact contribute to improved animal health and well being. In my institution each mouse cage has 63 sq.in. of floor space. Under the current guidelines that permit 5 mice per cage the proposed guidelines will restrict housing to 4 mice per cage and will only increase space per mouse by less than 20%. However, the increased costs of animal maintenance and facilities, in a time of reduced research funding will dramatically reduce the progress of research. Furthermore, it will have a negative impact on breeding of mice needed for research. Currently we use a breeding scenario in which two females are maintained with one male. This permits the females to share care of the pups, a situation especially critical when one of the females is a novice and needs to learn how to care for the pups. Otherwise there is significant loss of newborns. The new guidelines require that a female with litter would have to be housed individually, since there would only be 12 sq. in. remaining (63 sq in/cage – 51 sq in for mom with litter) – not "enough" space for a second adult mouse (which needs 15 sq in per these requirements). Thus, I would predict more loss of new-borns and, therefore, a situation that is not compatible with maintaining animal health and well-being that is the purported intent of the new guidelines. In addition, for a "standard" 2 female, one male breeding cage (which can currently remain together in a single cage as the females deliver pups and nurse them, and share care of the pups) this represents a > 200% increase in cages required over current standards with an associated increase in costs. For these reasons I am opposed to these new guidelines for mouse housing which: 1-have no basis in science and 2-do not promise an increase in animal health and well-being and 3-will result in significant cost increases at a time of reduced funding.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 146 [Entry Date] 04/18/2011 at 03:58:33 PM [Affiliation] Self [Organization City and State] Winston Salem, NC [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 147 [Entry Date] 04/18/2011 at 04:26:56 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 148 [Entry Date] 04/18/2011 at 05:24:19 PM [Affiliation] Organization [Organization Name] Washington University [Organization City and State] St. Louis, MO [Comments]

Output: Comment 1: Washington University in St. Louis is concerned about the substantive changes made to the Eighth Edition of the Guide for the Care and Use of Laboratory Animals. The 2011 Guide contains many recommendations that will, in effect, function like regulations, rather than guidelines. At over 200 pages (nearly double the size of its predecessor) the 2011 revision includes new and expanded coverage of the ethics of laboratory animal use; components of effective animal care and use programs (regulations, policies and principles; program management; program oversight; disaster planning and emergency preparedness); housing, environment, and enrichment for terrestrial and aquatic animals; veterinary and clinical care as well as physical plant characteristics. It contains more than 40 statements directing what institutions must do, including 29 newly-stated requirements. In addition, there are now approximately 660 "strong" recommendations. Although excellent new reference information from peer-reviewed scientific literature has been added in support of many subject areas, scientific evidence is lacking for changes in the recommended minimum housing space. In the Preface, the Committee acknowledges this deficiency, yet the new recommendations are still included. Of primary concern is the revision of minimum space for laboratory rodents: recommended space for a female and litter (mice) is 51 sq in and 124 sq in for rats. This would end the current practice of housing male/female rodent pairs and 1 male/2 female trios for breeding purposes in the standard cage used by most facilities. These recommendations pose significant operational, logistical, physical plant, personnel and financial obstacles. To follow all the Guide's provisions to qualify for NIH awards, PHS-assured institutions will likely spend a minimum of $100 million annually for increased costs of research animals, per diems, new caging and facility renovations. Some facilities will have no option but to reduce facility capacity to comply with new cage sizes. The limited opportunity for comment is insufficient in terms of both time and substance. A meaningful process for public input should be required. The current process limiting comments to 6,000 characters and requires comment submission by April 24, 2011 is simply insufficient to provide NIH with meaningful comments regarding the impact of this revision on institutional animal care and use programs. When comments are requested for the Guide under the requirements of OMB Bulletin No. 07-02: Final Bulletin for Agency Good Guidance Practices, no such limits should be in place. Washington University in St. Louis recommends that NIH not adopt the new Guide until these concerns are addressed.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 149 [Entry Date] 04/18/2011 at 05:29:21 PM [Affiliation] Self [Comments]

Output: Comment 1: This letter is submitted in response to the National Institutes of Health's solicitation of comments concerning the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). First, I would like to commend the Committee responsible for the 8th edition of the Guide on their significant effort in revising and updating the document to ensure that animal based research is conducted at the highest standard. With that said, I feel there is one significant change in the 8th edition of the Guide that has the potential to negatively impact animal based research, and as a result I cannot in good conscious recommend that OLAW adopt the Guide in its current format. More specifically, I am referring to the recommended cage sizes for female mice and rats with litters for which there is no scientific justification to support the recommendations. To put things in perspective, the average mouse box provides approximately 66 sq. in. of floor space whereas the Maxi-cage made by some companies provides approximately 75 sq. in. of space. In either case, the current caging systems available for mice would only support a monogamous pair based on the floor space recommendations in the 8th edition of the Guide. Though the Guide does indicate that "the interpretation of this table (space recommendations for group housed rodents) should take into account consideration the performance indices described in the text beginning on page 55", I have significant reservations that OLAW, which tends to be prescriptive in nature, will be able to use performance standards, in lieu of the recommendations in Table 3.2. In my opinion, the table could work for AAALAC; however, I am not confident it will work for OLAW. As a result, I truly believe that this issue needs to be resolved prior to OLAW adopting the Guide and/or that OMB be asked to look at the impact of the new Guide on the research enterprise in the U.S. The impact of the new recommendations for a female mouse with litter is significant. To move from a trio breeding system to a monogamous breeding system would have the following direct impact on the program for which I am associated: 1) the need to purchase an additional 6000 microisolator boxes; 2) the need to add 3 FTEs to the staff; 3) the need to add 5000 sq.ft. of animal housing space to the animal care program. The estimated cost to accommodate the new recommendations and go from a trio to a monogamous housing system would be approximately $2.2 million, of which a portion (new FTEs) would be recurring costs. The indirect impact would be greater cost to investigators for maintaining unique genetically engineered animals and a decrease in breeding indices. It is my belief, having worked in the field for over 23 years, that mice in trio breeding groups (1male/2females) have higher breeding indices, which may be attributed to a number of factors including: pheromone effects, social effects and shared parenting. In conclusion, I would recommend that OLAW not adopt the Guide until the issue related to cage sizes for female mice and rats with litters is resolved. If OLAW and NRC cannot resolve this issue then I would also recommend that the document be made available for public comment and that OMB be asked to review the economic impact of the new Guide on the nation's animal based research enterprise. Comment 2: Institutions should be given 1 year from the date the 8th edition of the Guide is adopted by OLAW to complete at least one semiannual program and facility evaluation. Since March 31, 2011 has passed, I would recommend that March 31, 2012 not be used and that it be tied to the date (1 year following) approval by OLAW of the 8th edition of the Guide.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 150 [Entry Date] 04/18/2011 at 05:38:12 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 151 [Entry Date] 04/18/2011 at 09:36:48 PM [Affiliation] Self [Organization Name] University of New England [Organization City and State] Biddeford, Maine [Comments]

Output: Comment 1: Comment 1: NIH requests public comments on whether it should adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service support for activities involving animals. Response: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: *********************************** Comment 2: NIH requests public comments on NIH's proposed implementation plan which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. Response: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 152 [Entry Date] 04/19/2011 at 01:59:14 AM [Affiliation] Self [Comments]

Output: Comment 1: NIH should NOT adopt the new Guide. Several provisions will dramatically impede biomedical research. In particular, the provision that all drugs given to animals (even rats and mice) must be pharmaceutical grade is wrongheaded. This and other provisions will hurt drug discovery. They will also increase the cost of doing research, i.e., they will dramatically reduce research productivity, while having zero positive effect on animal welfare. At a time of catastrophic deficits, severe threats to NIH funding, and a true crisis in drug discovery, the adoption of these guidelines is the LAST thing the country needs. Please, let common sense prevail and reject this new Guide.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 153 [Entry Date] 04/19/2011 at 07:47:29 AM [Affiliation] Self [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements will increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, there is no scientific data justifying these expense changes. The new "Guide" policies increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 154 [Entry Date] 04/19/2011 at 09:14:39 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 155 [Entry Date] 04/19/2011 at 09:48:11 AM [Affiliation] Self [Comments]

Output: Comment 1: NIH should develop its own guide!! Comment 2: The new guide is developed mainly with the inputs of IACUC administrators and veterinarians, not so much from principal investigators

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 156 [Entry Date] 04/19/2011 at 10:24:49 AM [Affiliation] Self [Comments]

Output: Comment 1: I strongly recommend that the 8th edition of the Guide NOT be adopted. The new edition was originally intended to be an "update" of the 1996 Guide; however, the resulting document goes far beyond revision by invoking new restrictions that have not been adequately considered or discussed. Moreover, this edition is twice as long and contains new "policy" for which there is little or no empirical justification. Compliance with these new "policy" statements will increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs) without providing any clear benefit to research, the use and care of animals, to agencies funding this work, or to the public that benefits most from research. Most importantly, there is no scientific data provided to justify the proposed changes in "policy". Adherence to the 2011 Guide will require a large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already are "overregulated." Moreover, the new "Guide" policies infringe on scientific decision-making by PHS grantees, contractors, and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. In summary, this edition of the Guide will seriously impede research activities without providing any clear benefit to any of the parties involved, including research animals. Comment 2: Institutional compliance with the new Guide should not occur before March, 2015 in order to allow for the collection of relevant data. These policies have been formulated without empirical support and any implementation of such a poorly concieved set of guidelines needs to be founded (or not) in information gathered over a broad range of conditions (institutions) and over several years of operation. Data, not opinion, should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 157 [Entry Date] 04/19/2011 at 10:38:09 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 158 [Entry Date] 04/19/2011 at 10:39:03 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 159 [Entry Date] 04/19/2011 at 10:41:52 AM [Affiliation] Self [Comments]

Output: Comment 1: NO, DO NOT ADOPT THE EIGHTH EDITION OF THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS. This guide imposes unnecessary regulations that will hinder research, not improve it. the increased paperwork and expense are prohibitive and sufficient safeguards on the care and use of lab animals are in place. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 160 [Entry Date] 04/19/2011 at 10:49:22 AM [Affiliation] Self [Comments]

Output: Comment 1: These recommendations for housing of research animals, particularly those proposed for rodents and primates, lack scientific or ethical justification, and will impose a large and entirely unproductive burden on the research community. They should not be enacted. Comment 2: The seventh edition of the Guide should be retained, without alteration in current reporting requirments.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 161 [Entry Date] 04/19/2011 at 10:55:06 AM [Affiliation] Organization [Organization Name] University of Maryland [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: The proposed new requirements for rodent and primate caging lack scientific justification. Further, there is no evidence that they will result in improved animal "well-being". Implementation of the new housing requirements would cost a tremendous amount of money without yielding any expected scientific or animal welfare benefit. This would be a huge waste of precious resources. Only if peer-reviewed objective data is subsequently produced that altered caging would likely result in improved animal welfare or more accurate scientific studies should revisions of this kind be reconsidered. Comment 2: The proposed 8th edition of the Guide should not be adopted, because the proposed new requirements for rodent and primate caging lack scientific justification. Further, there is no evidence that they will result in improved animal "well-being". Implementation of the new housing requirements would cost a tremendous amount of money without yielding any expected scientific or animal welfare benefit. This would be a huge waste of precious resources. Only if peer-reviewed objective data is subsequently produced that altered caging would likely result in improved animal welfare or more accurate scientific studies should revisions of this kind be reconsidered.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 162 [Entry Date] 04/19/2011 at 11:00:13 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 163 [Entry Date] 04/19/2011 at 11:02:53 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 164 [Entry Date] 04/19/2011 at 11:03:06 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will not enhance animal welfare but will result in significant additional expenses to the institute and investigators. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 165 [Entry Date] 04/19/2011 at 11:12:06 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 166 [Entry Date] 04/19/2011 at 11:32:21 AM [Affiliation] Self [Comments]

Output: Comment 1: NO. The compliance with these new "policy" statements will increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 167 [Entry Date] 04/19/2011 at 11:39:52 AM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 168 [Entry Date] 04/19/2011 at 11:48:50 AM [Affiliation] Self [Comments]

Output: Comment 1: No, NIH should not adopt the eighth edition of the Guide. Although this edition was intended to be an update of the 1996 Guide, the final product is twice as long and contains a great deal of new policy, suggesting that the eighth edition of the Guide is more than an update. Compliance with new policy statements will increase expense to institutions (e.g., cage size) and to investigators (e.g., drugs). Importantly, scientific data supporting the need for these changes do not exist; thus, the additional expense to institutions and investigators will be incurred with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures and multiple surgeries in an individual animal, new requirements for food- or fluid-restriction, significant constraints on choices of "chemicals and other substances" given to animals, and specific guidance on "post-approval" monitoring (e.g., observation of procedures). Adoption of the eighth edition of the Guide will substantially increase in paperwork burden (i.e., all deviations from "should" statements contained in the new Guide will need to be justified) and negate the opportunity to diminish the burden resulting from over reactions to issues that are already "overregulated" by institutions. Moreover, policies in the new Guide will dramatically increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. Comment 2: OLAW should require institutional compliance with the eighth edition of the Guide no sooner than March, 2015 to allow for the collection of relevant data, which should guide all policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 169 [Entry Date] 04/19/2011 at 12:22:44 PM [Affiliation] Organization [Organization Name] mount sinai [Organization City and State] new york, ny [Comments]

Output: Comment 1: The new regulations, if adopted, would place undue burden on animal research and greatly hinder our advancements. In addition,the specific recommendations included in this latest edition of the Guide for the Care and Use of Laboratory Animals are scientifically untested and extremely costly. Comment 2: Again, I'd forcefully add that the recommendations are scientifically untested and implementation of the regulations for facility evaluation by any date, but certainly by 2012, would place incredible financial strain on many struggling researchers and their institutions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 170 [Entry Date] 04/19/2011 at 12:28:12 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 171 [Entry Date] 04/19/2011 at 12:43:25 PM [Affiliation] Self [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 172 [Entry Date] 04/19/2011 at 01:10:39 PM [Affiliation] Organization [Organization Name] Wake Forest School of Medicine [Organization City and State] Winston-Salem, NC [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 173 [Entry Date] 04/19/2011 at 01:11:29 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 174 [Entry Date] 04/19/2011 at 01:12:15 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals


Input: [ID] 175 [Entry Date] 04/19/2011 at 01:12:29 PM [Affiliation] Organization [Organization Name] Wake Forest University School of medicine [Organization City and State] Winston Salem, North Carolina [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals