Input: [ID] 289 [Entry Date] 04/20/2011 at 03:55:20 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] 290 [Entry Date] 04/20/2011 at 04:13:04 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] 291 [Entry Date] 04/20/2011 at 04:16:47 PM [Affiliation] Self [Comments]

Output: Comment 1: No

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] 292 [Entry Date] 04/20/2011 at 04:18:17 PM [Affiliation] Organization [Organization Name] Lycoming College [Organization City and State] Williamsport, PA [Comments]

Output: Comment 1: I am writing as the chair of the Animal Care and Use Committe, and as a small animal researcher at Lycoming College, a small, exclusivley undergraduate, private liberal arts and sciences college in northcentral Pennsylvania. I have grave concerns over the proposed changes to the GCULA. First, there is no justification provided as to why the GCULA needed updating: what problems with animal welfare are the proposed changes supposed to address? Second, there are no data provided indicating the the proposed changes will in fact improve animal welfare significantly. Third, and most ominously, the added burden on small institutions such as Lycoming College, in terms of time, space, and money, is significantly increased by the proposed GCULA changes. If the changes are passed, it may no longer be feasible to conduct publishable animal research or provide animal research training for undergraduates at small institutions such as Lycoming College. I share these concerns with other faculty at small undergraduate institutions through my service as a Counselor with the Faculty for Undergraduate Neuroscience. We believe the current (7th) version of the GCULA serves the animals, the students, the colleges, and the nation's biomedical research enterprise quite well. We also believe that any significant changes to the GCULA must be justified by scientific data, which are lacking in this proposal. Moreover, we believe that the impact of changes on the nation's education and research infrastructure must be studied and taken into consideration before any changes are enacted. Comment 2: The proposed requirement for semiannual program and facility evaluation represents a significant burden for small undergraduate colleges. Who will pay for this review, which goes above and beyond what our own IACUC already does? And what scientific benefits will come from forcing more frequent reviews and documentation? Many small colleges like my own already struggle to do their animal research training under their teaching budgets, not subsidized by large national-level grants that provide "overhead" to the administration to defray such bureaucratic expenses. Mandating annual reviews will result in fewer undergraduate colleges providing animal research training to their students. This would not be in the nation's best interests, or in the best interests of animal research itself. If such a requirement is instituted, at the very least, there must be some sort of mechanism for smaller institutions to do their reviews at a different interval from the large, nationally-funded ones. Otherwise, substantial damage to the training opportunities for undergraduates will be the result.

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] 293 [Entry Date] 04/20/2011 at 04:22:08 PM [Affiliation] Self [Comments]

Output: Comment 1: There does not appear to be any rationale, supported by empirical evidence, for the need for a revised Guide. The revised Guide appears to have the force of a set of regulations with restrictions that can have a chilling effect on the use of animals in research and teaching. Furthermore, the substantial increased costs entailed in the Guide is likely to have the same effect on research with animals. Before the Guide is adopted there should be an opportunity for a thorough and meaningful review by agencies representing animal research and research scientists, such as the American Psychological Association, the Association for Psychological Science, and the National Association for Biological Research. Under the current deadline no such review is possible. Comment 2: For the reasons stated in Comment 1 concerning adoption of the revised Guide, there is no basis for implementing NIH's plan regarding facility evaluation that is based on that revised 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] 294 [Entry Date] 04/20/2011 at 04:23:33 PM [Affiliation] Self [Comments]

Output: Comment 1: I'm not sure that the current guide is lacking in its recommendations for the care and use of animals in research. The current guide seems to be useful for oversight and assistance at my institution and imposing additional regulations not only presents additional hurdles to researchers but could potentially create additional loopholes. The current guide is a fairly concise narrative given the broad scope of research carried out under its ethical purview. Comment 2: I'm not sure this new edition couldn't be considered a supplementary/elective document.

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] 295 [Entry Date] 04/20/2011 at 04:29:53 PM [Affiliation] Organization [Organization Name] Laboratory Animal Breeders Association [Organization City and State] Wilmington, Massachusetts [Comments]

Output: Comment 1: The Laboratory Animal Breeders Association recommends that OLAW not accept the 2011 Guide in its present form. We recognize the need for a guidance document for the US biomedical research community in order to set standards that take into consideration ethical responsibilities, animal welfare, and research concerns associated with the use of animals in research, teaching and testing. Such a document should leave room for professional judgment at an institutional level to apply performance standards in order to tailor practices and facilities to the needs of research animals. While the 2011 Guide acknowledges this principle, it sets forth, frequently as minimum standards, new engineering standards, new strong recommendations, and certain new prohibitions These standards, while similar to ETS 123, do not include the same caveats and hence, have more profound and costly unintended consequences. These stricter standards cannot be supported by peer-reviewed scientific studies. The level of specificity of guidance needs to be proportional to the robustness and specificity of the science supporting it. Such guidance should also still allow for the application of professional judgment and experience coupled with performance based measures applied at an institutional level using IACUC oversight to implement animal welfare based outcomes. In the case of the 2011 Guide, for example, the new cage space allocations for a mother with litter for rats and mice do not appear to be supported by robust science; yet, they will have an extreme negative impact in terms of costs, adherence to the principles of the three Rs, and depending upon how compliance is achieved, on animal welfare. If applied as a minimum standard, as suggested, they will have an extreme negative impact in terms of capital and operating costs, without commensurate benefit to the welfare of the animals. In some cases, not only is new guidance not supported by scientific evidence, it is contradictory to other guidance such as is the case in requiring that the floor space occupied by enrichment items be subtracted from the total floor area. Similarly, tightening of relative humidity ranges that is worded as a strong recommendation is not supported by scientific data yet will have a substantial operational and equipment cost impact on most facilities. In this case the strength of the recommendation is disproportionate to any theoretical positive animal welfare benefit. Clarification of the interpretation and application of this recommendation is not only needed but any strict application of this guidance should be justified at an institutional level based upon experience and professional judgment. Overall, we would recommend that OLAW gather more detailed information on issues associated with changes in the 2011 Guide before making a final decision. Based upon these concerns, an analysis of both the scientific justification for such additions and the financial impact of these additions should be undertaken especially if they are to be applied as minimum standards. Decisions on how the Guide will be used can then be made on a rational basis in proportion to the amount and strength of evidence supporting proposed changes in guidance. Comment 2: The Laboratory Animal Breeders Association agrees with OLAW that each institution should begin to make an assessment of areas of compliance and noncompliance with new guidance presented in the 2011 Guide. This evaluation should be completed by the deadline suggested. However, the evaluation should include, in addition to a timetable for compliance, a feasibility and economic impact statement for correcting areas of noncompliance. This is in keeping with our recommendation for a more robust analysis of new recommendations found within the 2011 Guide. Based upon this analysis, OLAW should decide if the Guide will be accepted as written and if so, should all recommendations be implemented; where significant economic impact is identified, should guidance be provided outlining reasonable and perhaps institution specific schedules for conformance or will certain recommendations require further scientific justification by an independent body such as the National Academy of Sciences perhaps using a group other than the Guide Committee assembled for this purpose. While animal welfare is an important component of biomedical research activities, recommendations for the care and use of laboratory animals need to be based on sufficient sound science and must consider the amount of resources that will be required to implement them. If such recommendations are limited or uncertain in their established ability for or level of improvement of animal welfare, if they are based principally on professional judgment, or if they do not consider all the variables that might impact their desired effect, they cannot be considered to be useful as universal guidance and certainly not be considered as minimum standards or strong recommendations. Moreover, they do not warrant wide spread application or the expenditure of disproportionate amounts of the ever decreasing resources available to the research community that will be required to implement them. The Laboratory Animal Breeders Association has calculated that at a minimum approximately $500 million in capital expenditures and $155 million dollars of increased operating expenses (not including amortization of capital expenses) will be required by its members to address some of the recommendations in the 2011 Guide. We feel that this level of expenditure when coupled with the estimates from the research community will merit more consideration of the strength of the scientific support for these recommendations before implementation should be considered.

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] 296 [Entry Date] 04/20/2011 at 04:32:03 PM [Affiliation] Self [Comments]

Output: Comment 1: Please continue to use the 1996 Guide as the standard for laboratory animal care. Teh new guidelines will severely limit the abilities of Investigators, especilly new investigators to perform quality research. Comment 2: If the new Guide is implemented, please allow at least four years for complete compliance. This will allow research institutions time to purchase and set up new, costly caging and other requirements.

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] 297 [Entry Date] 04/20/2011 at 04:32:25 PM [Affiliation] Organization [Organization Name] Medical College of Wisconsin [Organization City and State] Milwaukee, WI [Comments]

Output: Comment 1: The Medical College of Wisconsin (MCW) acknowledges the 8th edition of the Guide offers improved programmatic guidance in many respects, including expanded reliance upon peer-reviewed scientific literature as the basis for many recommendations. However, MCW has serious concerns about the potential impact of this document and cannot recommend its adoption by OLAW unless those concerns are addressed. Although the Guide contains several new recommendations that likely would result in additional programmatic costs, of preeminent concern to this institution are the new recommendations for minimum animal space, particularly for breeding rodents. Strict implementation of the new space recommendations would result in significant new start-up and recurring costs to this institution and its federal grant recipients. While such costs might be warranted if there was sound evidence demonstrating improved scientific outcomes or enhanced animal welfare, the new space recommendations are not based on any scientific investigations nor any data indicating the 1996 recommendations are inadequate. As such, the costs to implement the recommendations would be incurred for no proven benefit to science or animals. Like MCW, many academic institutions maintain large mouse breeding colonies, and we are confident many respondents will address concerns about the affects of the recommendations on investigations involving mice. However, MCW also maintains one of the largest academic research rat colonies in the world. We currently maintain more than 2,000 active breeding pairs and over 350 different inbred, transgenic, knockout, and consomic/congenic strains. These animals represent a unique, critically important resource for research conducted at MCW and around the country. Therefore, we chose to specifically illustrate the potential impact of the recommendations on this enterprise and the investigations it supports. In recent years MCW has invested more than $4 million to purchase individually ventilated cages (IVC) specifically to accommodate our growing breeding colonies of both rats and mice using the space recommendations of the 7th edition of the Guide. Each rat IVC provides approximately 140 sq. in. floor space. Nearly all of our rat breeders are set up as continuously co-housed monogamous pairs, and litters are raised in the cage with both parents. Implementation of the new space recommendations for a female rat with litter (table 3.2, page 57) would preclude this practice because our caging would not be big enough for a monogamous breeding pair plus a litter. This would necessitate separating each breeding pair prior to parturition and only re-pairing the animals after the litter has been weaned. Because separating the breeders like this would not permit mating during the female rat's postpartum estrus, the number of litters produced by each female would be reduced by nearly 50% per year. Subsequently, we would have to significantly increase the number of breeding animals and cages in order to maintain the current breeding colony production. We estimate this would cost the institution between $340,000 and $680,000 just for purchase of additional IVC caging. Furthermore, additional animal holding rooms would need to be freed up to accommodate the added caging, which may not be feasible. In addition to the cost to this institution for additional rat caging, the direct charges to grants for animal care also would increase markedly. Based on our current animal care costs/rates, the projected increase in the average daily census of rat cages needed to support the current level of research activity would translate to an additional $397,000 to $794,000 per year in animal care charges to investigators due to the change in housing density. And those charges would be compounded by the added personnel costs needed to separate and then re-pair breeders nearly 11,000 extra times per year. In the face of such increases in charges, especially in light of the current funding climate, investigators may be forced to cut back on or even abandon research projects involving rats, which would jeopardize the public investment already made in important projects. Although we detail above the perceived impact on research involving rat resources, MCW anticipates a similar, albeit somewhat less dramatic, impact on projects involving mouse breeding programs. We note the Guide does indicate that adjustments to the space recommendations may be reviewed and approved by the IACUC "based on performance indices related to animal well-being and research quality." However, from a practical perspective, the text on page 55 providing guidance on such indices illustrates several situations in which more space than that which is listed should be provided, but offers little in terms of situations in which less space would be acceptable. As such, it appears inevitable that the interpretation of the statement on page 56 that the listed space recommendations "should be considered the minimum" will result in their implementation as hard, engineering standards, and that any justification for providing less space than the "minimum" will be met by a high bar indeed. As a matter of precedent, OLAW's current guidance on whether IACUC's may approve deviations from the cage density recommendations states in part, "Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable." In summary, MCW does not recommend OLAW's adoption of the 8th edition of the Guide for the following reasons: a. The new recommended space for breeding rodents will result in significant additional costs to institutions and research programs. b. There is no scientific basis to support the recommended increase in space; therefore, the added costs to implement the recommendations would be for no demonstrable benefit. Comment 2: It will be feasible for the Medical College of Wisconsin to complete a semiannual program and facility evaluation using the 8th edition of the Guide by March 31, 2012. By that date, this institution will be able to determine the extent to which its animal care and use program conforms to the new Guide recommendations. However, we do not think it feasible to have implemented all of the new recommendations contained in the 8th edition of the Guide in that time frame. In particular, it would be unreasonable to expect that institutions could implement the new space recommendations for breeding rats and mice by the end of March next year without simply culling breeding stock and thus cutting back or curtailing research projects.

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] 298 [Entry Date] 04/20/2011 at 04:46:19 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] 299 [Entry Date] 04/20/2011 at 04:49:07 PM [Affiliation] Self [Organization Name] McLean Hospital, Harvard Medical School [Organization City and State] Watertown, MA [Comments]

Output: Comment 1: NO. Many of the recommendations contained in the 2011 Guide are not based on scientific evidence, and could seriously impede progress in research that will benefit public health. Most recommendations will require significant costly alterations for institutions and investigators. Examples of recommendations that have little scientific basis and could negatively impact research progress are as follows: The recommendation for use of pharmaceutical-grade drugs: There is no evidence that pharmaceutical-grade drugs would improve animal welfare. Moreover, research could be impeded because commercially available pharmaceutical-grade formulations are often single concentrations that make it difficult or impossible to manipulate drug dose or to compare different vehicles. Moreover, pharmaceutical-grade drugs will increase the cost of pharmacological research by 500 to 1,000 times in some instances. Recommendations for Constraints on multiple procedures in animals: It is often in the best interest of science to conduct longitudinal studies in animal subjects using repeated measures in an own control design. Some nonhuman primates live for more than 25 years, and repeated measures are often necessary to answer research questions. Repeated surgeries are often necessary to repair or prolong the life of surgically implanted experimental devices. Recommendations for Paired housing for nonhuman primates: Despite the attractive "face validity" of paired housing and the opportunity for physical contact between pairs of nonhuman primates recommended in the 2011 Guide, this would place animals at risk for injury and death. Aggression in response to any surprise (a novel noise, person, pain, etc.) may lead the dominant member of the pair to attack/kill the weaker or more submissive cage mate. Studies that require implantation of any device such as an IV catheter to evaluate medication effectiveness could not be conducted. Recommendations for Changes in cage size: There is no scientific justification for modifications in cage sizes and configurations specified in the 1996 edition of the Guide. The cost to institutions and to investigators would be astronomical! Comment 2: Implementation of any changes to the 1996 Guide should be delayed for at least five years (March 2015) to allow NIH to gather scientific evidence to support or to refute the many problematic recommendations proposed in the 2011 Guide. The requirement for additional oversight will add to an already onerous regulatory burden that eventually will be unsustainable for many research institutions. The ultimate impact will be serious damage to this nation's preeminent leadership in health-related research. The NIH must recognize that lobbying efforts by groups opposed to all research with animals, such as the Humane Society of America and the Physicians for Social Responsibility, are reflected in the proposed changes to the Guide. It would be most unfortunate if NIH standards for insuring animal welfare were primarily influenced by the well-funded political agenda of those organizations opposed to all research on animals, rather than humane concerns for animal welfare and commitment to advances in science.

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] 300 [Entry Date] 04/20/2011 at 04:56:01 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] 301 [Entry Date] 04/20/2011 at 04:56:31 PM [Affiliation] Self [Comments]

Output: Comment 1: I cannot recommend acceptance of this document in it's current form. The document represents a drastic change from historical version switching from advisory to regulatory. Further, the cost of implementation, particularly with respect to rodent housing, will have marked implications on the quantity and quality of research that can be performed as housing facilities will host less animals, there will be a significant increase in initial capital requirements - at a time that my institution is facing another 92 million dollar budget cut (and has already sustained 120+ million in cuts in the previous 4 years) and the obvious increase in the costs of animals will have major implications on our research funding in this grant period and beyond. Implementation of this guide at the current time is ill-advised and in many cases (admittedly, within the document) based on poor scientific evidence. Animal research models are critical for the long term implementation of NIH-funded research, as well as research funded by other organizations, and the long-term effects that the new version of the guide would have on such research could be devastating. I strongly urge you not to consider this guide until significant c hanges are made.

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] 302 [Entry Date] 04/20/2011 at 05:12:11 PM [Affiliation] Self [Comments]

Output: Comment 1: The NIH should NOT adopt the eighth edition 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] 303 [Entry Date] 04/20/2011 at 05:25:21 PM [Affiliation] Self [Comments]

Output: Comment 1: NO! The new policies represent an unjustified infringement on scientific decision-making by PHS grantees, contractors and IRGs. They result in more expenses without any enhancement of animal welfare. Comment 2: To allow collection of relevant data, institutional compliance should be deferred until at least march 2015.

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] 304 [Entry Date] 04/20/2011 at 05:27:41 PM [Affiliation] Self [Organization Name] Oberlin College [Organization City and State] Oberlin OH [Comments]

Output: Comment 1: It should not be adopted. There are many reasons but I wish to emphasize the increased intrusion on scientific research that is not based on sufficient scientific data. The fact that the increased intrusiveness will increase the costs to teacher/scholars at smaller institutions may have devastating effects on students. What appears to be small changes to a committee in Washington will nudge significant numbers of scientists at small liberal arts colleges to move away from animal research (it has already happened and this would make it worse) thus stunting the experience and world view of many of those students who are now going on to get PhDs. Comment 2: This too is excessive for small 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] 305 [Entry Date] 04/20/2011 at 05:34:09 PM [Affiliation] Self [Comments]

Output: Comment 1: I have considerable concern about the increased floor space requirement for female mice with litters to 51 square inches. This new requirement essentially eliminates the potential for continuous breeding of trio groups (1 male, 2 female) in standard sized mouse caging and will significantly increase the time and cost burden of mouse research, which comprises >90% of research animals used in most animal care programs. There there is no scientific justification for this change, it imposes a strict engineering standard regardless of litter size, and it will have a signficant negative impact on the ability of mutant strains to reproduce due to the exclusion of shared maternal nurturing and failure to utilize the post-partum estrus. I urge the NIH to not adopt the 2011 version of the Guide until this new requirement is specifically excluded. I also agree with all of the other statements made in the NABR response to the potential adoption of the 2011 ILAR Guide by the NIH as the standard for laboratory animal care, which is available at http://click.icptrack.com/icp/relay.php?r=15987687&msgid=326524&act=RZO4&c=248297&destination=http%3A%2F%2Fwww.nabr.org%2FNABR_Draft_Comments_On_Guide_MSWord.aspx Comment 2: See above and the NABR response to the proposal to utilize the 2011 Guide. I feel this version should not be implemented and the 1996 Guide should remain the officially recognized document until the 2011 version of the Guide is revised sufficiently to remove the costly and unnecessary burden on research that its current form imposes.

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] 306 [Entry Date] 04/20/2011 at 06:19:27 PM [Affiliation] Self [Comments]

Output: Comment 1: I would strongly suggest that NIH does not accept the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in the Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). This guide has several flaws including guidelines which would appear to become rules. I am particularly focusing on the new guidelines for rodent housing which have been developed by "judgment and experience" (direct quote from the document) rather than scientific research. To subject researchers across the country to regulations developed by feel and individual use and not directly from controlled studies (or reflective of my individual use) is clearly not correct and certainly beneath the scientific underpinning of NIH. Time must be given for the discussion of the new guidelines (and adequate space for online submission) to be fully vetted by parties that will be subject to these guidelines and the possibility that needed modification can occur before simply adopting the document. Thank you for listening and considering these comments from just a regular researcher out in a lab whose research and budget will be severely impacted by the adoption of these guidelines.

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] 307 [Entry Date] 04/20/2011 at 06:50:12 PM [Affiliation] Self [Comments]

Output: Comment 1: I do NOT support NIH's adoption of the new Guide for the Care and Use of Laboratory Animals. Major organizations like the American Psychological Association (APA), the Association for Behavior Analysis International (ABAI), and the American Society for Pharmacology and Experimental Therapeutics (ASPET) have outlined many of the concerns that researchers in this country, like me, have with the new guide. I support their statements regarding the adoption of the new Guide and have little to add. In short, the major concerns I have deal with increased cost to institutions without any clear benefit or empirically supported improvement in animal welfare. The wording of the new Guide, if adopted, would result in virtual mandates (the "should" comments) that would increase expenditures, e.g., new caging, no multiple procedures, restrictions on food and water intake, increased paperwork, use of pharmaceutical-grade agents (Guide p. 31), without any data to suggest that the new policies are an improvement over the current practices. For example, many researchers have used non-pharmaceutical-grade drugs for decades with no ill effects to the animals. Switching to pharmaceutical-grade drugs would only add cost without improvement to animal welfare. This is just one example where the Guide's recommendations, which would become "law" for many IACUCs, are not empirically supported and would pose an unreasonable burden on researchers and institutions. While many animal researchers support guidelines for maintaining and improving animal welfare, the new Guide, which lacks empirical support for many recommendations, misses the mark. Of course, animal welfare is important to scientists, but asking institutions to change practices at enormous financial costs without data to support the necessity of the changes, is misguided. In sum, I strongly believe that the NIH should NOT adopt the new Guide. Comment 2: n/a

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] 308 [Entry Date] 04/20/2011 at 07:58:15 PM [Affiliation] Self [Comments]

Output: Comment 1: NO, it should not adopt it. the Eighth Edition of the Guide for the Care and Use of Laboratory Animals is a clear example of over-regulation. The issue of a new guide was considered and deemed unnecessary a while back, yet here we have a new draft. Furthermore this guide seeks to empower animal investigation committees that have proven much easier to infiltrate by animal rights activists. Often our only recourse to sanity has been the federal regulations. At the very least it seems to me you should have a broad and extensive consultation with animal researchers to fully consider the consequences of these regulations vis a vis their potential benefits. The process up to now seems arbitrary and unnecessarily rushed. Comment 2: No, there should be no seminannual program and facility evaluation using the eighth 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] 309 [Entry Date] 04/20/2011 at 08:06:31 PM [Affiliation] Self [Comments]

Output: Comment 1: I oppose the adoption of the eighth edition. After reviewing the proposed guide, I am struck by the large increase in regulation and paperwork for investigators and research institutions. This increase would make conduct of important research more expensive, in an economic situation that makes funding of research harder to provide. At the same time, increases in scientific research are critical to our economic recovery. I know of no evidence that the current regulations fail to adequately ensure the safety and humane treatment of research animals. In all, it is

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] 310 [Entry Date] 04/20/2011 at 08:40:40 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] 311 [Entry Date] 04/20/2011 at 08:42:59 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: 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] 312 [Entry Date] 04/20/2011 at 09:14:33 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, if indeed, the Guide is used to direct policy. 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] 313 [Entry Date] 04/20/2011 at 09:40:07 PM [Affiliation] Organization [Organization Name] University of Maryland [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: I oppose the adoption of the new edition of the guide. The eighth edition contains many unjustified revisions, and appear making many poorly informed assertions. The goal of medical research is to find new treatments for illnesses by scientists based on their best training and knowledge. Deferring judgement on what quality and quantity of new preparations on animal testing from scientists to regulatory bodies for animal care ans welfare is inappropriate.

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] 314 [Entry Date] 04/20/2011 at 11:48:44 PM [Affiliation] Self [Comments]

Output: Comment 1: I would encourage continued use of the 1996 guide. Use of pharmaceutical grade drugs would increase the cost of doing research, and decrease the amount of research being done. Comment 2: 4 years would be a much more reasonable amount of time. The changes proposed will be expensive, and require time.

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] 315 [Entry Date] 04/21/2011 at 07:10:42 AM [Affiliation] Self [Comments]

Output: Comment 1: As a research psychologist involved in NIH-funded research, I am submitting comments on the proposed adoption and implementation of the 8th edition of the Guide for the Care and Use of Laboratory Animals (new Guide) as Public Health Service (PHS) Policy. I have carefully reviewed and compared the new Guide to existing PHS Policy, which is based on the 7th edition of the Guide (1996 Guide). Because research with laboratory animals is an integral component of my research, I strongly support efforts to improve laboratory animal welfare but, at the same time, believe that it is necessary to ensure that proposed policies or regulations are soundly based and do not compromise scientific research. As a result, while the new Guide appears to be a well-crafted resource that aims to strike a balance between the needs of research and the welfare of laboratory animals, at this time I cannot recommend that NIH adopt the 8th edition of Guide as PHS Policy. In particular, I am concerned that: 1) the new Guide contains many recommendations that will, in effect, function like regulations, rather than the "guidelines" for the care and use of research animals authorized by the Health Research Extension Act of 1985; 2) insufficient scientific evidence is presented regarding impact on animal welfare for some major revisions reflected in the new Guide; and 3) the additional provisions will have a significant economic impact on PHS-assured institutions. Therefore, I believe that the 1996 Guide should remain PHS policy and that the new Guide be used as a reference document. Given that the 6000 character limit for comments precludes the ability to provide a detailed response, this response will highlight areas of concern for my own research, as well as that of colleagues in the behavioral and psychological sciences who conduct research with laboratory animals. The new Guide contains more than 40 statements about what institutions "must" do (defined as "actions that are imperative and mandatory duty requirements"), including 29 newly-stated requirements. In addition, there are approximately 660 recommendations that researchers "should" do (defined as "a strong recommendation for achieving a goal" but noting that "individual circumstances might justify an alternative strategy"). Both sets of statements have the unintended consequence of being viewed and implemented as policy rather than guidance – policies that the research community has not had a chance to review and comment on in a substantive manner. Furthermore, some of these mandatory requirements are particularly problematic because they constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. The new Guide is extraordinarily prescriptive on a number of topics, without empirical evidence that the recommended action enhances the welfare of the lab animals. Compliance with these new standards will greatly increase the cost of conducting research with laboratory animals with no evidence of commensurate improvement in animal welfare. The increased cost will be further compounded by increased regulatory and paperwork burden, in terms of justifications, requests for exceptions, and additional recordkeeping. Areas of particular concern are: (a) IACUC responsibilities – new requirements for post-approval monitoring and formal review of "unexpected outcomes" will require additional staffing and recordkeeping; (b) Surgery -- the caution against multiple major survival surgical procedures not only increases costs because of the increase in number of animals required, but also interferes with the scientific integrity of the study by not allowing the use of within-subject and single subject designs that are particularly powerful for behavioral research; (c) Food/fluid regulation – a new requirement to keep written records of both daily food and fluid consumption for animals under either restriction precludes the use of commonly used automatic watering devices, even when water is not restricted. Further, the recommendation that "a highly preferred food or fluid be used as positive reinforcement, instead of restriction" for "conditioned-response research protocols" is made despite information provided in the cited papers that such strategies do not work well to train behaviors – one of many examples of guidance that is inappropriate, both scientifically and for ensuring appropriate use of laboratory animals; (d) Use of Non-Pharmaceutical Grade Chemicals and Other Substances – this new policy is based on false premises. For example, not only do very few commercially available preparations exist that are suitable as tools for experimental research but they are also subject to formulation errors. Also, in psychopharmacological research, including studies such as those I conduct, the commercially available preparations would need to be altered (diluted to particular dose concentrations and filtered), increasing rather than decreasing the margin of error. Given that these commercial preparations are also substantially more expense, this is an increased regulatory burden, with concomitant expense, but with no evidence of benefit. I concur with the National Association for Biomedical Research (NABR) that the new Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB). Therefore, an opportunity for comment in greater detail from the research community on the substance of the new Guide and its financial consequences is necessary before a decision on the adoption of the new Guide as PHS Policy is made and an implementation strategy instituted. Comment 2: If the Office of Laboratory Animal Welfare does decide to adopt the new Guide as PHS Policy, I strongly believe that the March 2012 deadline for compliance with the new standards is unrealistic and recommend a more gradual 4-5 year phase-in. Changes in requirements for cage sizes, watering systems, pharmaceuticals, etc. would require purchase of new equipment, all without concomitant changes in NIH funding for the projects affected. Given that budgets for currently funded projects were not developed with the new policies in mind, adoption by March 2012 would, in many cases, represent a substantial financial burden. Further, institutions would require time to prepare for the increased paperwork and regulatory burden, which may involve hiring of new personel and development of new accountability systems - burdens which the institutions will be required to bear without the opportunity for advance financial planning.

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] 316 [Entry Date] 04/21/2011 at 07:41:57 AM [Affiliation] Self [Comments]

Output: Comment 1: April 12, 2011 To Whom It May Concern, I am quite concerned about the mouse breeder cage occupancy guidelines as proposed in the most recent Guide for the Care and Use of Laboratory Animals. The 51 in2 requirement for a single female with a litter would make monogamous pairing the only possible housing arrangement for the standard mouse cage (81 in2). This will dramatically increase the cost of maintaining mice and is counter to what is reported in the scientific literature on the effects of housing density on mouse biological parameters. Peters A, Festing M. Population density and growth rate in laboratory mice. 1990. Lab Anim 24:273-279. Smith AL, Mabus SL, Stockwell JD, Muir C. Effects of housing density and cage floor space on C57BL/6J mice. 2004. Comp Med 54:656-663. Smith AL, Mabus, SL, Muir C, Woo Y. Effects of housing density and cage floor space on three strains of young adult inbred mice. 2005. Comp Med 55: 368-376. Davidson LPO, Chedester AL, Cole MN. Effects of cage density on behavior in young adult mice. 2007. Comp Med 57:355-359. Laber K. Veatch LM, Lopez MF, Mulligan JK, Lathers DM. Effects of housing density on weight gain, immune function, behavior and plasma corticosterone concerntrations in BALB/c and C57BL/6 mice. 2008. J Am Assoc Lab Anim Sci 47:16-23. In addition, the guidelines go beyond the European guidelines as outlined in the Council of European Convention which is counter to attempts to harmonize guidelines between different geographic regions.. For most academic institutions in the United States the options are to house breeding mice in monogamous pairs or purchase all new caging. One of the problems with housing mice in monogamous pairs is that there is less social interaction between mice, and it is my experience based upon work with rodents for over 25 years that mice breed better in a social setting. In short, the specific requirement to house a female male with a litter at 51 in is a bad standard and should be changed to be more consistent with European standards (a single male and two females in a standard sized mouse cage). Respectfully Submitted, ***** Comment 2: recommend implementation one year after OLAW acceptance.

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] 317 [Entry Date] 04/21/2011 at 08:02:59 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] 318 [Entry Date] 04/21/2011 at 08:57:53 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] 319 [Entry Date] 04/21/2011 at 09:19:07 AM [Affiliation] Self [Comments]

Output: Comment 1: No.Oppose approval of the 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] 320 [Entry Date] 04/21/2011 at 09:24:51 AM [Affiliation] Organization [Organization Name] BRAINnet foundation [Organization City and State] Sam Fransisco, CA [Comments]

Output: Comment 1: No, the NIH should not adopt the 8th edition of the Guide. There is no supporting data for the proposed 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] 321 [Entry Date] 04/21/2011 at 09:34:51 AM [Affiliation] Self [Comments]

Output: Comment 1: The new restrictions and costs associated with adopting the new Guide will impose upon significant additional burdens on researchers. As far as I can see, there are no data to indicate the Guide needs changing. It is not clear what problems the changes are trying to remedy. There is no empirical justifications that the additional measures and restrictions will result in a significant improvement in animal welfare. Finally, the additional costs and paperwork are unduly burdensome, especially for institutions that have limited funds.

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] 322 [Entry Date] 04/21/2011 at 10:51:50 AM [Affiliation] Self [Comments]

Output: Comment 1: NO! This new version substantially rewrites policy, and does so in contradiction to a great deal of literature on animal welfare, including some of the literature it cites for support! In its present form it will severely restrict ongoing research and impose huge costs across biomedical research. Comment 2: I do not agree with the implementation plan for using the eighth edition as the basis for evaluation by March 31, 2012. This shoud be postponed until Mar. 2015 to allow the correction of errors in the eight edition, and to permit sufficient time to upgrade facilities.

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] 323 [Entry Date] 04/21/2011 at 10:54:45 AM [Affiliation] Self [Comments]

Output: Comment 1: The adoption of these proposed guidelines, which seem to have been formulated without any scientific data, will significantly increase the obstacles to the development of new disease treatments. I urge the Public Health Service to reject these 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] 324 [Entry Date] 04/21/2011 at 11:07:45 AM [Affiliation] Self [Comments]

Output: Comment 1: I feel that the guide should not be accepted in its present form. I specifically have issues with the non-pharmaceutical grade drug policy. There is no reliable data suggesting that the mandated use of pharmaceutical grade drugs (PGD) will increase the health or welfare of research animals. The use of PGDs will have several negative consequences. 1) needless expense, there are huge differences in the cost of PGD vs chemically pure versions of the same drug. Cost is a major issue in view of the diminishing research dollars that are provided at taxpayers expense. Pure cost-benefit analysis alone makes this a ridiculous policy. 2)PGDs are less readily available. The commercial formulations of PGDs make precise and accurate pharmacological studies (dose-response, toxicology) very difficult because of the inactive and active ingredients, difficulties in dilution, administration, compounding etc. 3) New/experimental compounds are not PGD, the time and bureaucratic expense of documenting and justifying non PGDs in unnecessary and unwarranted and does not provide any benefit to the animals involved.

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] 325 [Entry Date] 04/21/2011 at 11:30:09 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.

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] 326 [Entry Date] 04/21/2011 at 11:35:07 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] 327 [Entry Date] 04/21/2011 at 11:42:31 AM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [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, na?ve 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] 328 [Entry Date] 04/21/2011 at 12:31:33 PM [Affiliation] Organization [Organization Name] Aragon Pharmaceuticals [Organization City and State] San Diego CA [Comments]

Output: Comment 1: We are opposed to the new requirement that new cage sizes for continual pair mating in a cage that is 65 square inches cannot be done – the female would have to be separated from the male. This greatly reduces the productivity of the maiting, leading to increased animal use, increased husbandry costs or a significant investment in new capital equipment.

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] 329 [Entry Date] 04/21/2011 at 12:45:36 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] 330 [Entry Date] 04/21/2011 at 12:53:21 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] 331 [Entry Date] 04/21/2011 at 01:01:16 PM [Affiliation] Self [Comments]

Output: Comment 1: please don't more paperwork without scientific justification. Comment 2: please don't

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] 332 [Entry Date] 04/21/2011 at 02:08:36 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [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] 333 [Entry Date] 04/21/2011 at 02:13:36 PM [Affiliation] Self [Comments]

Output: Comment 1: Retain the 1996 guide Comment 2: If new guidelines are adopted, extend compliance date to March 2015.

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] 334 [Entry Date] 04/21/2011 at 02:16:35 PM [Affiliation] Self [Comments]

Output: Comment 1: I think that the guide should NOT be adopted for evaluation of institutional programs.

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] 335 [Entry Date] 04/21/2011 at 02:16:53 PM [Affiliation] Self [Organization City and State] Morganton, NC 28655 [Comments]

Output: Comment 1: I vote against adopting the new Guide as policy, maintaining adherence to the 1996 Guide. A similar public comment period in 2005–2006 yielded the conclusion that no substantive revisions to the existing Guide were needed. Comment 2: If the 2011 Guide is adopted as PHS policy, I suggest a time frame of at least 4 years (e.g., 2015)in which PHS-assured institutions and NIH intramural programs should be required to comply given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research 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] 336 [Entry Date] 04/21/2011 at 02:16:57 PM [Affiliation] Self [Comments]

Output: Comment 1: The newest edition of the guide has a great deal of useful new information. There is a discussion of the 3R's for the first time, along with a clarification of what constitutes an animal care and use program. The protocol review section has been expanded to cover unexpected events and humane endpoints, along with expansion of food/fluid regulation. The section on post-approval monitoring is particularly timely. The new sections on aquatics and specialized animal facilities (imaging, etc) provide relevant guidance to both scientists and veterinarians. The quality & quantity of new guidance far outweighs any concerns regarding additional compliance requirements/suggestions (i.e., new musts/shoulds). Comment 2: This is a sufficient period of time following release of the new Guide to incorporate changes into existing animal care and use programs.

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] 337 [Entry Date] 04/21/2011 at 02:17:46 PM [Affiliation] Self [Comments]

Output: Comment 1: THE PROPOSED CHANGES ARE TOO COMPLEX AND WILL INCREASE THE COST OF RESEARCH WITHOUT INCREASING THE SAFETY OR HEALTH OF LABORATORY ANIMALS.THESE CHANGES SHOULD NOT BE IMPLEMENTED.

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] 338 [Entry Date] 04/21/2011 at 02:19:14 PM [Affiliation] Self [Comments]

Output: Comment 1: I believe that the 1996 Guide is sufficient (as was concluded in the 2005-06 assessment), and vote against adopting the new guide. Comment 2: Research institutions are struggling with severe budget cutbacks. At least 4 years should be provided.

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] 339 [Entry Date] 04/21/2011 at 02:25:54 PM [Affiliation] Self [Comments]

Output: Comment 1: Do not adopt. The guide will increase the authority of local IACUCs to restrict already peer-reviewed research. Although some of the new recommendations are based on empirical research, many are not (e.g., cage sizes, food and liquid restriction). Comment 2: I recommend a 4 year deadline given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research 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] 340 [Entry Date] 04/21/2011 at 02:26:43 PM [Affiliation] Self [Comments]

Output: Comment 1: I vote OLAW should retain the 1996 Guide as PHS policy Comment 2: I STRONGLY recommend at least 4 years if not more (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research 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] 341 [Entry Date] 04/21/2011 at 02:27:03 PM [Affiliation] Organization [Organization Name] The Kolburne School [Organization City and State] New Marlboro, MA [Comments]

Output: Comment 1: I recommend that the 8th edition in it's current revision NOT be adopted as a standard for the use and care of animals in a laboratory setting. Furthermore, I recommend the 1996 standards stay in effect until the 8th edition can be further refined. Comment 2: I vote against this timeline. I recommend at least 4 years (March 31, 2015) given the expense of a variety of cage size and housing requirements during a time of great financial difficulty for research 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] 342 [Entry Date] 04/21/2011 at 02:29:50 PM [Affiliation] Organization [Organization Name] University of North Texas [Organization City and State] Denton, TX [Comments]

Output: Comment 1: Consider at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements at a time of great financial difficulty for research 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] 343 [Entry Date] 04/21/2011 at 02:33:37 PM [Affiliation] Self [Comments]

Output: Comment 1: I recommend that the OLAW NOT adopt these new guidelines as policy. I feel that the 1996 version of the Guide is sufficient and that no substantial changes to the current Guide is warrented or necessary. Comment 2: I believe that, if the 8th edition of the Guide is adopted, full-scale implementation of it should not be required for at least four (4) years (i.e., 2015). The nation, as a whole, is faced with extreme economic difficulties at present, and these new incurred costs will be detrimental to sceintific 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] 344 [Entry Date] 04/21/2011 at 02:37:42 PM [Affiliation] Self [Comments]

Output: Comment 1: The NIH should not adopt these guidelines. Comment 2: Four years (2015) seems like a more appropriate time frame.

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] 345 [Entry Date] 04/21/2011 at 02:37:48 PM [Affiliation] Self [Comments]

Output: Comment 1: The current regulations are quite sufficient and the onerous increases proposed would put many productive research laboratories under tremendous financial strain, hindering their ability to contribute to the greater good of their field and public health in general. These guidelines are not based in empirical research. Animals utilized for research purposes are incredibly healthy, and every effort is already made to ensure their continued vitality and to minimize pain and distress during and following any procedure. Comment 2: At a time of great financial difficulty for our research institutions, who are competing for ever fewer research dollars, putting taxpayer dollars in to superfluous regulatory activities is not the rational choice. Many, many laboratories simply would not have the funds to meet the new requirements, and many hardworking and productive researchers and graduate students would be left with no way to pursue their ideas and goals for new 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] 346 [Entry Date] 04/21/2011 at 02:38:05 PM [Affiliation] Self [Comments]

Output: Comment 1: I wish to vote against adopting the new Guide as 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] 347 [Entry Date] 04/21/2011 at 02:40:59 PM [Affiliation] Self [Comments]

Output: Comment 1: Adopt. Comment 2: Standardized fidelity of implementation checklist completed by local site manager, with simultaneous inter-observer agreement data collected by NIH supervisor.

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] 348 [Entry Date] 04/21/2011 at 02:41:20 PM [Affiliation] Self [Comments]

Output: Comment 1: Re: NIH's Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals My comments regarding 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 the Federal Register on February 24, 2011 (76 Federal Register 10379 – 80) are as follows: (1) The 2011 Guide contains many recommendations that will, in effect, function like regulations, rather than the "guidelines" for the care and use of research animals authorized by the Health Research Extension Act of 1985 (2) There is insufficient scientific evidence for some revisions reflected in the new Guide; (3) The additional provisions of the 2011 Guide will have a significant economic impact on PHS-assured institutions such as my home institution, The University of Arizona. I ask that NIH not adopt the new Guide until the above concerns are addressed. I suggest that the 2011 Guide be reviewed for consistency with the Office of Management and Budget's (OMB) Bulletin No. 07-02: Final Bulletin for Agency Good Guidance Practices, specifically the definitions, standards, notice and public comment provisions regarding "significant guidance document[s]", "economically significant guidance document[s]" and "regulatory action" (72 Federal Register 3432-40). In view of the Guide's general applicability, scope, depth, complexity, and effect of setting NIH policies regarding the humane care and use of laboratory animals in PHS supported activities, it is reasonable to assume that NIH's adoption of the 2011 Guide would qualify the Guide as a "guidance document" as defined by OMB. To follow all the Guide's provisions in order to qualify for NIH awards, the more than 1,100 PHS-assured institutions will likely spend a minimum of $100 million annually. I believe changes in the guide will significantly increase the cost of research at our insitution, which will impact our ability to continue biomedical research goals, which relate directly to human health and welfare. I believe it is imperative for the animal research community to have a meaningful opportunity to comment on the substance of the new Guide and its financial consequences so that NIH can formulate an appropriate, well-informed implementation plan. Thank you. Comment 2: I believe you need to delay your plan by one year, given the signficant issues that remain before implementation and the difficulty research facilities will have in fully evaluating and complying with this extensive document.

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] 349 [Entry Date] 04/21/2011 at 02:41:32 PM [Affiliation] Self [Comments]

Output: Comment 1: I recommend that you DO NOT ADOPT as policy the eighth edition of the new Guide, that you continue to maintain adherence to the 1996 Guide as policy. Many state budgets - as here in Texas - have huge deficits that are resulting in major cuts to education. The new Guide would suffice to be the deathknell to many of our research programs. Furthermore, many of the recommended policies in the eighth Guide are not empirically supported. That these are mandated without having been exposed to scientific rigor is curious indeed. Comment 2: Should the eighth Guide be adopted, please postpone the implementation until 2015. Perhaps that would give us time to more thoroughly investigate your proposals. Indeed, it would give the scientific community a bigger window in which to prepare for the mandated changes. Thank you for this opportunity to comment.

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] 350 [Entry Date] 04/21/2011 at 02:43:12 PM [Affiliation] Organization [Organization Name] Behavioral Pharmacology Division of ASPET [Organization City and State] Chapel Hill, 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