Input: [ID] 226 [Entry Date] 04/20/2011 at 09:11:08 AM [Affiliation] Organization [Organization Name] Winston Salem State University [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] 227 [Entry Date] 04/20/2011 at 09:14:53 AM [Affiliation] Organization [Organization Name] Wake Forest University School of Medicine [Organization City and State] Winston-Salem, North Carolina [Comments]

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

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


Input: [ID] 228 [Entry Date] 04/20/2011 at 09:16:28 AM [Affiliation] Organization [Organization Name] Wake Forest Univeristy School of Medicine [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 229 [Entry Date] 04/20/2011 at 09:33:49 AM [Affiliation] Self [Comments]

Output: Comment 1: 1)there is no evidence that using pharmaceutical grade drugs would improve animal welfare or science; 2) commercial pharmaceutical grade formulations make careful pharmacological research difficult as these are single concentration formulations, which makes manipulating dose and vehicle comparisons difficult while at the same time maintaining pharmaceutical grade standard 3) The regulation is burdensome without benefit to animal welfare or 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] 230 [Entry Date] 04/20/2011 at 09:39:56 AM [Affiliation] Organization [Organization Name] Wake Forest University [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. Data should drive decisions! 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] 231 [Entry Date] 04/20/2011 at 09:46:04 AM [Affiliation] Organization [Organization Name] Winston Salem State University Biomedical Research Infrastructure Center [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] 232 [Entry Date] 04/20/2011 at 09:50:10 AM [Affiliation] Organization [Organization Name] Wake Forest University School of Medicine [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 233 [Entry Date] 04/20/2011 at 09:59:28 AM [Affiliation] Self [Comments]

Output: Comment 1: I appreciate the focus of the new Guide remaining on performance standards rather than engineering standards. Having said that, there are a couple of items which appear to apply engineering standards in a manor which will have a signficant economic impact on the animal care program at the institution I am employed at. Specifically, the implied requirement to eliminate mouse harem breeding will significantly impact the requirement for ventilated mouse caging as well as impact the per diems needed to accomplish the aims of existing NIH grants since we charge for daily animal care by the mouse cage, not the individual mouse. Both of these items represent a signficant cost to our animal care program. We currently have 20,000 mouse cages, approximately half of which are breeding colony cages. The new Guide would double the number of cages needed for breeding colonies, representing an additional 71 ventilated racks of 140 cages each. The cost of this caging is currently $2.5 million for the 71 racks. The animal care budget of our existing NIH grant utilizing mouse breeding colonies would need approximately 2.6 million annually for the remainder period of the grant (10,000 cages x 0.72/cage x 365 days/yr) The estimated total direct economic impact at our institution would therefore be anywhere from $5.1M to $10.3M depending on the duration left on the grants. While this is a staggering amount when multiplied by the number of institutions that may be impacted, if there was scientific evidence to support this change, I would not object to the expense in the long run. HOWEVER, since there is NOT scientific evidence to support this change in mouse breeding cage space, I am not in favor of this guideline revision due to the significant negative economic impact it will have. Finally, it would appear that IACUC would no longer be able to approved programmatic exceptions to the Guide, but rather have to do that on an individual protocol basis. This too would appear to enhance the regulatory burden on the IACUC and decrease IACUC efficiency without benefit to the overall animal care and use program. I hope you will consider these two items and reword the 8th Guide document to relieve the economic and regulatory burden posed by this new edition when it would not enhance the animal care program in my professional opinion. Comment 2: Due to the economic impact of the new Guide as it applies to rodent breeding cage density, it is not feasible to obtain the funding or the caging in time to meet the March 2012 timeframe of implementation.

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] 234 [Entry Date] 04/20/2011 at 10:04:47 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] 235 [Entry Date] 04/20/2011 at 10:40:04 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. 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. Again, the only way to ensure that these changes do enhance animal welfare, which should be the goal for all researchers, is to examine relevant data. In situations for which there is no relevant data, it is inappropriate to propose fixed policy. 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] 236 [Entry Date] 04/20/2011 at 10:46:15 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] 237 [Entry Date] 04/20/2011 at 11:02:40 AM [Affiliation] Self [Comments]

Output: Comment 1: NIH should not adopt the new guidebook. The 1996 version is adequate to insure animal well being. Local IACUC regulations can mandate to specific policies to investigators with inuput from complete IACUC committees. Comment 2: Semiannual facilities inspections are appropriate.

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] 238 [Entry Date] 04/20/2011 at 11:13:26 AM [Affiliation] Self [Comments]

Output: Comment 1: No, this should not be adopted. Comment 2: No, this is an unnecessary burden.

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] 239 [Entry Date] 04/20/2011 at 11:13:52 AM [Affiliation] Self [Organization Name] University of Maryland School of Medicine [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: No Comment 2: March, 2015 or later for the collection of relevant data. Data 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] 240 [Entry Date] 04/20/2011 at 11:18:34 AM [Affiliation] Self [Comments]

Output: Comment 1: I OPPOSE the adoption of the 8th Edition of the Guide. The new specifications DO NOT represent an improvement on laboratory animal condition housing, but WILL cause an enormous MIS-SPENDING of now limited resources. I personally talked to several animal facility Veterinarians, and they all strongly oppose the directives including in this guide. The costs of implementation will be gigantic, and the benefits in terms of animal welfare will be ZERO. Comment 2: March 31, 2012 is too soon for an evaluation. Evaluations should be based on data, which may take some time to be collected.

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] 241 [Entry Date] 04/20/2011 at 11:22:53 AM [Affiliation] Self [Comments]

Output: Comment 1: I believe OLAW should retain 1996 Guide as PHS Policy. My general concerns about the new edition include increased expense (e.g., new cage sizes for rodent breeding; larger cages for newly mandated social housing), increased paperwork burden (For example, all deviations from "should" statements contained in the new Guide will need to be in an approved protocol), and the increased power of local IACUCs to restrict already peer-reviewed research. Futhermore, I am specifically concerned about the constraints on multiple procedures in animals, constraints on multiple surgeries (not just multiple major survival surgeries), increased constraints governing food- or fluid-restriction, and poorly conceived instruction dictating the use of "chemicals and other substances" in laboratory animals. Comment 2: I recommend at least 4 years (e.g., 2015) given the expense of a variety of cage size and housing requirements that are being required 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] 242 [Entry Date] 04/20/2011 at 11:24:15 AM [Affiliation] Self [Comments]

Output: Comment 1: The new guide (Eighth edition) should NOT be approved. It contains instances of over-regulation that will impede reasonable research. For example, stipulations regarding the use of pharmaceutical grade drugs in all cases are unworkable, burdensome in its requirements for approval of use of "non-pharmaceutical" drugs, and will end up significantly impeding research. Many changes, though well-intentioned, are very poorly thought out as to their consequences. Comment 2: This seems to be, in accord with a number of other changes proposed for the Guide, unnecessarily burdensome.

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] 243 [Entry Date] 04/20/2011 at 11:24:25 AM [Affiliation] Organization [Organization Name] The Mount Sinai School of Medicine [Organization City and State] New York, NY [Comments]

Output: Comment 1: No. The NIH should abide by the recommendations of the working group that reviewed the prior public comment request and concluded that the 1996 Guide should not be revised with respect to policies and procedures. Comment 2: Same as above

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] 244 [Entry Date] 04/20/2011 at 11:25:22 AM [Affiliation] Self [Comments]

Output: Comment 1: I am writing to object to the new guidelines. They are not necessary and will inject more hurdles into the job of medical research. The net result of these changes will be to prevent life saving treatments from being developed. The existing guidelines are quite effective in insuring that animal cruelty does not occur. Untold millions of human beings will suffer if medical research is further impeded.

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] 245 [Entry Date] 04/20/2011 at 11:26:51 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] 246 [Entry Date] 04/20/2011 at 11:27:29 AM [Affiliation] Self [Comments]

Output: Comment 1: I strongly advocate NOT adopting the 8th edition. It creates mischief that will actually HARM the care and use of laboratory animals. The new guide is not an "update" of the 1996 Guide, but is much longer and contains a great deal of new "policy", most of which is ill-founded, illogical, very expensive, and yet has no support from scientific data that would justify such changes. Moreover, the 2011 Guide will dramatically increase paperwork without any benefit to animal subjects or to the underlying research that may impact on human health. This flies in the face of general efforts to reduce bureaucratic overhead. In light of the lack of scientific basis for the new regulations, one wonders about the motivation for them and where scientific and veterinary input was during their creation. Comment 2: No, there needs to be relevant data collected to guide policy decisions. OLAW should require institutional compliance with the new Guide no sooner than 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] 247 [Entry Date] 04/20/2011 at 11:29:13 AM [Affiliation] Self [Comments]

Output: Comment 1: NO it should not adopt this edition as a basis for evaluation of institutional programs.The new guide is not an "update" as originally proposed but contains a great deal of new "policy." Compliance with these new "policy" statements will greatly increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). Moreover, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden. Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will 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. THE END RESULT WOULD BE TO SEVERELY IMPEDE ADVANCES MADE BY BASIC RESEARCH WITH NO GAIN IN ANIMAL WELFARE.

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] 248 [Entry Date] 04/20/2011 at 11:32:38 AM [Affiliation] Self [Comments]

Output: Comment 1: No, do not adopt this edition. The prior comment period consensus was that no revision to the Guide was warranted. This current revision is a great example of bureaucratic mission creep and should be used throughout the government's various entities as an example of how not to interact with the interest groups affected by the agency. How about waiting until we request a revision to the Guide or at least agree that one is needed before launching such an unnecessary effort. Comment 2: No, see above.

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] 249 [Entry Date] 04/20/2011 at 11:34:12 AM [Affiliation] Self [Organization Name] Tufts University [Organization City and State] Medford, Massachusetts [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an "update" of the 1996 Guide, however, the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements will increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). As a researcher I depend on newly developed drugs with therapeutic potential. These substances are investigational drugs. They need to be studied before being developed further for clinical use in human and veterinary medicine. However, the scientific data justifying the expense changes for using larger cages and pharmaceutical grade drugs are 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, proven 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 (in spite of data to the contrary), 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] 250 [Entry Date] 04/20/2011 at 11:48:08 AM [Affiliation] Self [Comments]

Output: Comment 1: The revised version of the Guide should NOT be approved in its present form. The new Guide, supposedly an update, is now twice as long and contains a great deal of new, highly-biased "policy." Compliance with these new mandates will do little for animal welfare but at the same time it will increase the expense to institutions (e.g., cage size) and the expense to investigators (e.g., drugs). Even worse, there are NO data to support any of these unfunded mandates. Adherence to the proposed Guide will unduly increase the paperwork burden since any deviations from "should" statements require justification ad infinitum. 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 (thus INCREASING the number of animals in an experiment), 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). Comment 2: Be serious....OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data on the validity of the plethora of regulations. It is the data that should guide policy decisions, not highly-biased anti-vivisection extremists.

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] 251 [Entry Date] 04/20/2011 at 11:52:07 AM [Affiliation] Self [Comments]

Output: Comment 1: No. The 8th addition should not be adopted as it includes substantial and expensive changes that are not supported by data that such changes will improve either animal husbandry or research quality. Comment 2: This time frame seems much too short given the number of issues that need to addressed with real data.

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] 252 [Entry Date] 04/20/2011 at 12:04:15 PM [Affiliation] Self [Comments]

Output: Comment 1: Quite simply, no. NIH should not adopt the 8th edition of the Guide. Many of the changes (and there are extensive changes rather than simply an update) are new directives that are based on hearsay rather than objective data from peer-reviewed publications. This extends a problem already present, but to a lesser degree, with the previous edition. Comment 2: One cannot base reviews on a poorly generated document that lacks scientific rigor. Recommend that we do not implement the semiannual review/evaluation based on guidelines promulgated in the 8th edition.

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] 253 [Entry Date] 04/20/2011 at 12:04:36 PM [Affiliation] Self [Organization Name] University of Arkansas for Medical Sciences [Organization City and State] Little Rock, AR [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 are likely to increase the expense to institutions, particularly in implementing new cage size limits; as well as expense to investigators to pay for increased cages. Investigators will also need to purchase drugs at increased costs to meet the new regulations. In neither case is there any scientific data justifying these new regulations. Without data showing that current guidelines are inadequate, there is little basis for changing them. 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." 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 to justify the new regulations. Without data showing that current guidelines are inadequate, the new regulations are questionable at best.

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] 254 [Entry Date] 04/20/2011 at 12:11:57 PM [Affiliation] Self [Comments]

Output: Comment 1: No, this should not be adopted. Comment 2: No, more time is needed before requiring compliance to insure sufficient experience with new guidelines to understand problems that will be introduced that will unnecessarily impede progress in biomedical 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] 255 [Entry Date] 04/20/2011 at 12:14:46 PM [Affiliation] Self [Comments]

Output: Comment 1: NO - do not adopt this guide The new guide was originally supposed to be an "update" of the 1996 Guide. However, the new guide is twice as long and contains a great deal of new "policy." The key problem is a lack of any scientific rationale for the changes. Compliance with this immensely burdensome approach will increase the expense to taxpayers, require large increases in paperwork burden, infringe on scientific based decisions, and slow progress in biomedical discovery and treatment development. At the end of the day, this guide will provide NO REAL IMPROVEMENT in animal welfare, but impede science and medicine. Comment 2: This new Guide should be tabled and only data driven approaches should be utilized for 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] 256 [Entry Date] 04/20/2011 at 12:14:57 PM [Affiliation] Self [Comments]

Output: Comment 1: I do NOT think the New 2011 Guide should be adopted in its present form. I have listed my concerns below: 1) The use of non pharmaceutical grade chemicals (page 31). What had previously been restricted to anesthetic and analgesic agents, because of the language, could now theoretically be applied to ALL chemicals we administer to our subjects. This will dramatically increase the cost of resaerch without any scietific justification for this new requirement. 2) Food and water restriction and the level of monitoring of these animals that will be required (page 30). No distinction appears to be made between the monitoring required regardless of whether the subjects are food restricted OR fluid restricted. In other words, the language reads that daily food and water consumption and hydration must be monitored for both types of restrictions. Again - what is the scientific justification for these chagnes and if implemented this new requirement will greatly increase the record keeping requirements. 3) Cage sizes - particularly for breeding animals. Basically, there is room only for a mouse dam and litter, no harem breeding. For rats, I do not believe that many single cages are large enough for the dam and pups (ventilated rack cages are definitely not large enough), it will require oversized cages. These issues bring up concerns about additional costs and crowding in our already overcrowded facilities. 4) While many of the changes are listed as "should"s versus "must"s there is also a great deal of concern about OLAW's distinction between the two with several people saying that while the "Guide" makes the distinction OLAW does not. I also feel that while AALAC and many IACUC committees will take a reasonable approach regarding "must"s and "shold"s in the new Guide, I am concerned that outside animal activist groups will simply use these changes as addditonal "weapons" to impede research - perhaps by filing lawsuits to "enforce" these new regulations as THEY (or the courts) interpret them.

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] 257 [Entry Date] 04/20/2011 at 12:26:06 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] 258 [Entry Date] 04/20/2011 at 12:29:23 PM [Affiliation] Self [Comments]

Output: Comment 1: I urge the NIH to NOT adopt the eight edition of the Guide. We will not be able to comply with the requirement to use only pharmaceutical grade drugs in rodent studies. There are no pharmaceutical grade formulations available for several of the drugs we routinely use for our studies, including cocaine. For other drugs, the pharmaceutical grade formulations are significantly more expensive. These additional costs were not budgeted into our grants and will result in a drastic decrease in our research productivity. Ultimately, this may lead to the loss of research funding and jobs, which will negatively impact human health, science, and the US economy. Comment 2: I urge the NIH to NOT adopt the eight edition of the Guide. We will not be able to comply with the requirement to use only pharmaceutical grade drugs in rodent studies. There are no pharmaceutical grade formulations available for several of the drugs we routinely use for our studies, including cocaine. For other drugs, the pharmaceutical grade formulations are significantly more expensive. These additional costs were not budgeted into our grants and will result in a drastic decrease in our research productivity. Ultimately, this may lead to the loss of research funding and jobs, which will negatively impact human health, science, and the US economy.

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] 259 [Entry Date] 04/20/2011 at 12:30:59 PM [Affiliation] Self [Comments]

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

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


Input: [ID] 260 [Entry Date] 04/20/2011 at 12:45:29 PM [Affiliation] Organization [Organization Name] Univeristy of California, San Diego [Organization City and State] La Jolla, CA [Comments]

Output: Comment 1: The 8th edition of the guide is flawed, and should not be adopted for a number of reasons. I will list the primary three: The first is a substantial increase in research costs due to the housing requirement changes, that have no scientific backing in terms of improving animal health over the current housing recommendations. The second is even more important, the requirement to use pharmaceutical grade drugs in research. Not only do very few commercially available preparations exist that are suitable as tools for experimental research, but also, commercial solutions themselves are subject to formulation errors, as evidenced by recent recalls. Even with solutions that may be useful for a particular project, the need to conduct dose-effect evaluations inevitably means the commercial solution would need to be diluted in the laboratory to accomplish this purpose. Third: by changing the already very rigourous recommendations of the guide yet again, the paperwork/implementation/regulatory burden that is created is astronomical. I am an IACUC member of my institution and the added burden of complying with the new recommendations (some of which are written in very vague or downright illogical manners) will be extensive on an already "tipped to the breaking point" group of scientists and administrators. Scientists already have to spend more and more time writing grants becuase of the reduced payline, more and more time on regulatory paperwork and administrative duties required by funding and other agencies, the time alloted to research and scientific discovery is shrinking continuously. The guide's consequences of reducing time devoted to research for no clearly defined benefit to the quality of research will only undermine further health care research, and does not support the NIH mission. Comment 2: Why, in a time of reduced funding to NIH are we requiring yet more time wasted from already incredibily burdened NIH and other institutional adminstrators and scientists? The amount of time spent already on protocol review, laboratory and vivarium inspections is more than enough to ensure proper animal care and handling in research. Animals in laboratories are the MOST well cared for animals on the planet. At this time, adding yet more contraints and regulations to research in the form of changing animal research guidlelines with no clear reason to do so at a time of 8% funding paylines does not seem logical or helpful. These changes will require NIH funded scientists to spend yet more time NOT on science but on paperwork, committees, and administrative reviews. This is, in my opinion, not the time for NIH to be focusing on poorly considered changes to animal regulations, but instead on things more important to the core NIH mission, which is conducting and supporting the best scientific research for improving human health.

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] 261 [Entry Date] 04/20/2011 at 12:50:29 PM [Affiliation] Self [Organization Name] University of California [Organization City and State] Irvine California [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] 262 [Entry Date] 04/20/2011 at 12:52:42 PM [Affiliation] Self [Comments]

Output: Comment 1: My answer is NO it should not adopt this edition. The edition has a number of changes that will impair medical research and should be strongly opposed by all humanitarians.

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] 263 [Entry Date] 04/20/2011 at 01:02:52 PM [Affiliation] Self [Comments]

Output: Comment 1: As a board-certified laboratory animal veterinarian with 30 years of experience, and as an AAALAC Council member Emeritus, I strongly endorse adoption of the eighth edition of the Guide. The new edition provides valuable new information, including material on aquatic species, and forms a framework for eventual harmonization of animal care practices world-wide. In my view, this new edition is five years overdue. Failure to adopt it would mean that facilities that care for and use research animals would remain without a useful guiding document for the foreseeable future. Comment 2: As an ACLAM diplomate and former member of the AAALAC International Council on Accreditation, I support the proposed implementation time frame of approximately one year. There are no new elements of the Guide that could not be addressed by institutions within that period.

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] 264 [Entry Date] 04/20/2011 at 01:03:46 PM [Affiliation] Organization [Organization Name] American Society for Pharmacology & Experimental Therapeutics [Organization City and State] Bethesda, MD [Comments]

Output: Comment 1: The Association for Pharmacology and Experimental Therapeutics (ASPET) comprises 4800 members who are experts in research across a wide range of specialties, as indicated by the names of its divisions: Behavioral Pharmacology, Cardiovascular Pharmacology, Drug Discovery & Development Drug Metabolism, Molecular Pharmacology, Neuropharmacology, Toxicology, and Translational & Clinical Pharmacology. ASPET urges OLAW not to adopt the 2011 edition of the Guide. Its deviation from the 1996 Guide will result in a significant increase in regulatory and paperwork burden and expense without benefit to animal welfare. ASPET supports the comments of NABR that were submitted to Francis Collins, Director of NIH. Our comments will focus on the newly added section "Use of Non-Pharmaceutical Grade Chemicals [NPC] and Other Substances," which adds new policy to the Guide that is unwarranted with respect to animal welfare or good research practice. Albeit well intended, this policy is not well informed regarding the conduct of research that uses drugs in laboratory animals. One problem with the new guidance on NPC is that the term "pharmaceutical grade" is not defined, nor does an accepted definition exist. An indication of its intended meaning is Guide citation of USDA/APHIS Policy 3, which covers "sedatives, analgesics, or anesthetics" used to prevent pain/distress with regulated species. Its use of "non-pharmaceutical grade" refers to medications not prepared for clinical use. The Guide extends Policy 3 terminology to all vertebrates and all chemicals used in research. The implication is that all solutions prepared by a researcher are considered of inferior quality and that clinical solutions are ideal for research, neither of which is accurate. Specifically, ASPET notes the following with respect to the four sentences on NPC in the Guide: (1) "The use of pharmaceutical grade chemicals. . .ensures that toxic or unwanted side effects are not introduced into studies. . . ." The use of commercially prepared solutions does not ensure this. There are many examples of commercial solutions being recalled. Mass manufacture of pharmaceutical grade drugs amplifies any error. (2) "They should therefore be used, when available, for all animal-related procedures. . ." The assertion that clinical formulations are superior for all-animal-related procedures is neither logical nor supported by scientific evidence. Laboratory-prepared formulations have been the norm in research for the last century. There is no evidence that research or animal welfare would be improved by changing this research practice. The way in which drugs are formulated for clinical use make them poor choices for research. For example, dose manipulations are essential to research. Unlike clinical use, volume of drug delivery needs to be held constant. The single concentrations of solutions sold commercially inevitably need to be diluted to manipulate dose. The assumed benefit of using a commercial solution is lost. Another element of good research is comparison of the effects of the drug with that of vehicle alone. Vehicles of commercial solutions cannot easily be duplicated. (3) "The use of [NPCs] should be described and justified in the animal use protocol and be approved by the IACUC. . . for example, the use of [NPC] may be necessary to meet the goals of a project or when a veterinary or human pharmaceutical-grade product is unavailable." The wording implies the need for an NPC is unusual. In reality, it is the rule. The vast majority of animal research involves compounds that are not used clinically. New chemical entities are keys to advances in science and public health. Collaborations with academic, government, or industry chemists are common; many high purity compounds are available from highly regarded commercial sources. Drug supply programs at NIH make controlled substances and other compounds not formulated for use in humans available to researchers without cost, as do biotechnical and pharmaceutical firms. To require that each use of an "NPC" be justified in writing and reviewed and approved by an IACUC places an unwarranted paperwork burden on researchers and on the IACUC. (4) "Consideration should be given to the grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics of the chemical or substance to be administered, as well as animal welfare and scientific issues relating to its use (NIH 2008)." These considerations are applicable to veterinary care, but are of more variable relevance to research. A part of each research project that uses chemical compounds necessarily involves determining details of their use that will assure the meaningful characterization of the effects of the compound. ASPET suggests that requiring these to be spelled out in advance, and reviewed and approved by the IACUC singles out pharmacology research for micromanagement--a function that has not been the traditional goal or value of the Guide. Note also that the citation is to an intramural NIH guideline, which defines "pharmaceutical grade" differently than does USDA/APHIS Policy 3. In summary, the newly added Guide requirement to use drugs formulated for clinical use in research animals is not realistic. For the few situations in which such a drug might be available, the practical needs of research make them unsuitable, and the cost, compared to one suited for laboratory can be significant (e.g., up to 10-fold). To require NIH's drug supply programs to substitute clinical-use solutions for all those it currently provides via its drug supply programs would be an expense that does not justify use of scarce research dollars. Should OLAW adopt the 2011 Guide, ASPET urges that it consult NIH Institute Directors regarding the wisdom of including the NPC section as PHS Policy. Comment 2: ASPET concurs with NABR that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, setting a date by which PHS-Assured institutions must comply with the new Guide prior to an OMB analysis of its financial impact on those institutions and NIH itself is premature.

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] 265 [Entry Date] 04/20/2011 at 01:29:20 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new guide contains a great deal of new "policy", in which compliance with these new "policy" statements may increase the expense to institutions and 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. 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. Comment 2: OLAW should require institutional compliance with the new Guide at a much later date 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] 266 [Entry Date] 04/20/2011 at 01:33:39 PM [Affiliation] Self [Organization City and State] Shreveport, LA [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] 267 [Entry Date] 04/20/2011 at 01:35:44 PM [Affiliation] Self [Comments]

Output: Comment 1: I oppose the adoption of the new guide since it places significant burdens on scientists with little additional protection for the animals. Comment 2: I believe you should allow more time for evaluation before fully implementing 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] 268 [Entry Date] 04/20/2011 at 01:39:42 PM [Affiliation] Organization [Organization Name] UT Southwestern Medical Center [Organization City and State] Dallas, TX [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] 269 [Entry Date] 04/20/2011 at 01:41:13 PM [Affiliation] Self [Comments]

Output: Comment 1: No Comment 2: 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] 270 [Entry Date] 04/20/2011 at 01:41:24 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] 271 [Entry Date] 04/20/2011 at 01:49:52 PM [Affiliation] Self [Organization Name] Center for neurobiology and Behavior, U. of Pennsylvania [Organization City and State] Phila., PA [Comments]

Output: Comment 1: No, the NIH should not adopt this 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] 272 [Entry Date] 04/20/2011 at 02:11:11 PM [Affiliation] Self [Organization Name] Keck School of Medicine of University of Southern California [Organization City and State] Los Angeles, CA [Comments]

Output: Comment 1: No, the NIH should not adopt the new guidelines. Comment 2: No, the evaluation program is redundant, expensive and will impede research. The administrative load the the NIH is proposing to impose will utilize precious resources that would be directed to paper work and not to improvement of care of animals used in scientific research. It would do exactly the opposite of what the NIH wishes to accomplish. An annual evaluation schedule would provide outstanding monitoring.

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] 273 [Entry Date] 04/20/2011 at 02:11:52 PM [Affiliation] Self [Organization Name] Emory University [Organization City and State] Atlanta, GA [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" that will restrict research and increase the expense to researchers and institutions WITHOUT ANY CLEAR BENEFIT TO ANIMAL WELFARE. These suggested changes have been made in the COMPLETE ABSENCE OF SCIENTIFIC DATA supporting them. Comment 2: NO. 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] 274 [Entry Date] 04/20/2011 at 02:18:49 PM [Affiliation] Self [Comments]

Output: Comment 1: The proposed changes will impose unnecessary overregulation of experimental details. Investigators need to design each experiment to optimize animal safety and scientific value, and excessive regulation interferes with these decisions. Comment 2: I recommend that the impositions of new policies be deferred to May, 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] 275 [Entry Date] 04/20/2011 at 02:37:20 PM [Affiliation] Self [Comments]

Output: Comment 1: NO 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] 276 [Entry Date] 04/20/2011 at 02:40:53 PM [Affiliation] Organization [Organization Name] The University of Toledo [Organization City and State] Toledo, OH [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 a large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies will cause 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. Collectively, these new policies attempt to install unnecessary restrictions and protocol in scientific animal research and attempt to govern scientific inquiry with ineffective and redundant bureaucracy. 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. Until properly evaluated, these new policies may slow existing research and introduce unneeded confusion to animal protocol.

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] 277 [Entry Date] 04/20/2011 at 02:50:05 PM [Affiliation] Self [Comments]

Output: Comment 1: The major shortcoming of the new Guide is the lack of empirical data to justify the additional expenses that will be incurred by principle investigators (PIs) and their institutions to accommodate the proposed new changes. The chapter on veterinary care (Chapter 4 in the proposed new Guide) is no exception. In general, the proposed new changes clearly mandate increased consultation and oversight of veterinarians, beyond what the 1996 Guide required. In and of itself, increased veterinarian oversight of all aspects of care and use of animals may, indeed, be a good thing. However, the questions that are not addressed are why, and at what cost? Would hiring more veterinarians for consultation and supervision significantly increase animal care at institutions that are following the 1996 Guide? Is it worth the additional costs for PIs and institutions to employ this extra supervision, if they are experiencing no problems and if their IACUCs are satisfied with the present care and use of animals at their institution's facilities? Perhaps some institutions can afford this, but there are many others that are on the brink of closing their animal facilities because of the escalating costs, and the educational, societal, and economic impact these closings could have may far outweigh whatever unspecified shortcomings the proposed new guidelines have been created to address. The proposed new Guide (Ch 2, page 14) makes the attending veterinarian (AV) responsible for all animal care and welfare. If an IACUC interprets this strictly, they may decide to mandate the hiring of a full-time AV, which may be prohibitively costly for some institutions. The proposed new Guide also puts more emphasis on the role of the AV in reviewing the health status of animals from non-commercial sources (Ch 4, page 108), selecting anesthetics and analgesics (Ch 4, pages 116 and 121), use of neuromuscular drugs (Ch 4, pages 122-123), and standard methods of euthanasia (Ch 4, pages 124). Although few would object to having more AV involvement in animal care and use, there are no data to indicate that these changes are necessary, nor were any cost/benefit analyses for mandating such changes cited. Is the current AV oversight role insufficient for appropriate animal care? Haven't the trained animal care technicians, PIs, and the institutional IACUCs, who have been responsible for much of this monitoring of animal care during the past 30 years, been doing an adequate job? The cost burden of increasing the involvement of an AV may be too high for some institutions to continue to conduct animal research, and it seems grossly unfair to impose this on institutions whose animal care programs have been functioning extremely well under the present guidelines, when there is no evidence to indicate that many of the changes in the new proposed Guide is needed at all, let alone if they will result in a significant improvement to the welfare of the animals at these institutions. Comment 2: First, I do not see a need for this proposednew Guide. Is there a report or data that suggests that the existing Guide is not adequately protecting the welfare of laboratory animals? Is the added costs and burdens of the proposed new Guide resolving some problem of which many of us have not been notified? Adopting the proposed new Guide in time for inspections by March 31, 2012 is an excellent example of how out of touch the beauracracy is concerning the issues researchers using animals are facing. It is unreasonable to impose these measures in such a short time frame. It is especially onerous considering that most of the new stipulations are unncessary, restrictive, and costly. At the very least, a thorough cost/benefit analysis for implementing the new Guide should be mandated BEFORE any suggestion of an adoption date be forwarded.

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] 278 [Entry Date] 04/20/2011 at 03:08:26 PM [Affiliation] Organization [Organization Name] Wake Forest University School of Medicine [Organization City and State] Winston Salem, NC [Comments]

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

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


Input: [ID] 279 [Entry Date] 04/20/2011 at 03:16:29 PM [Affiliation] Organization [Organization Name] Wake Forest University [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] 280 [Entry Date] 04/20/2011 at 03:17:37 PM [Affiliation] Organization [Organization Name] Winston salem state university [Organization City and State] winston salem, NC [Comments]

Output: Comment 1: 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 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] 281 [Entry Date] 04/20/2011 at 03:18:14 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). 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] 282 [Entry Date] 04/20/2011 at 03:23:57 PM [Affiliation] Self [Comments]

Output: Comment 1: No compelling need for any changes on current policy. So, I vote NO for 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] 283 [Entry Date] 04/20/2011 at 03:33:25 PM [Affiliation] Self [Comments]

Output: Comment 1: Response: 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: Response: 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] 284 [Entry Date] 04/20/2011 at 03:38:24 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. This combination of decreasing support for research while at the same time making research more far expensive to conduct shows an astounding lack of foresight and is creating a major crisis for our country at a time when we need to be promoting innovation and making dollars go further. 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] 285 [Entry Date] 04/20/2011 at 03:43:50 PM [Affiliation] Self [Comments]

Output: Comment 1: No -- NIH should NOT adopt the 8th edition as the basis for evaluating institutions that receive PHS support. 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] 286 [Entry Date] 04/20/2011 at 03:47:30 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] 287 [Entry Date] 04/20/2011 at 03:48:12 PM [Affiliation] Self [Organization Name] Whitman College [Organization City and State] Walla Walla, WA [Comments]

Output: Comment 1: I support fully the comments and concerns put forth by NABR. They have done an outstanding job of evaluating the new edition, and raising substantive objections. There is no sound rationale for this expansion beyond creating more mid-level administrator positions. The current edition does an excellent job of ensuring responsible, humane treatment of animals in laboratory settings. Comment 2: There is no scientific data supporting the vast expansion of the proposed eighth edition of this guide, and as someone conducting research at a small liberal arts college, the added administrative burden will kill our ability to do effective research with our already limited amount of time, and interfere with our ability to train effectively the next generation of scientists in animal research. Somewhere, someone needs to decide what is enough and use reason to draw a line. I hope that the NIH is able to do so at this time. Please reject this new edition.

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] 288 [Entry Date] 04/20/2011 at 03:54:05 PM [Affiliation] Self [Organization Name] Wake Forest University School of Medicine [Organization City and State] Winston Salem, NC [Comments]

Output: Comment 1: NO. The new guide was originally supposed to be an ?update? of the 1996 Guide, however the final product is twice as long and contains a great deal of new ?policy.? Compliance with these new ?policy? statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from ?should? statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have ?overregulated.? Moreover, the new ?Guide? policies Increased infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, 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