Input: [ID] 176 [Entry Date] 04/19/2011 at 01:15:28 PM [Affiliation] Self [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 177 [Entry Date] 04/19/2011 at 01:17:00 PM [Affiliation] Organization [Organization Name] Wake Forest School of Medicine [Organization City and State] Winston-Salem, NC 27157 [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] 178 [Entry Date] 04/19/2011 at 01:23:27 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 "over-regulated." 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] 179 [Entry Date] 04/19/2011 at 01:33:43 PM [Affiliation] Organization [Organization Name] Wake Forest School of Medicine [Organization City and State] Winston Salem, NC [Comments]

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

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


Input: [ID] 180 [Entry Date] 04/19/2011 at 01:33:58 PM [Affiliation] Organization [Organization Name] WFBH [Organization City and State] Winston Salem NC [Comments]

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

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


Input: [ID] 181 [Entry Date] 04/19/2011 at 01:36:33 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] 182 [Entry Date] 04/19/2011 at 01:37:09 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [Organization City and State] Winston-Salem, NC 27157 [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] 183 [Entry Date] 04/19/2011 at 01:37:12 PM [Affiliation] Organization [Organization Name] Wake Forest Baptist Health [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] 184 [Entry Date] 04/19/2011 at 01:39:45 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] 185 [Entry Date] 04/19/2011 at 01:39:53 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [Organization City and State] Winston Salem NC [Comments]

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

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


Input: [ID] 186 [Entry Date] 04/19/2011 at 01:58:49 PM [Affiliation] Organization [Organization Name] Wake Forest School of Medicine [Organization City and State] Winston Salem, NC [Comments]

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

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


Input: [ID] 187 [Entry Date] 04/19/2011 at 02:06:02 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 188 [Entry Date] 04/19/2011 at 02:12:52 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] 189 [Entry Date] 04/19/2011 at 02:30:16 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] 190 [Entry Date] 04/19/2011 at 02:36:31 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. Please do not adopt the proposed 8th edition of the Guide. First of all, it goes way beyond what was originally recommened as an update to the 1996 edition and will increase costs associated with research for both researchers and institutions. Why these changes are being proposed is not based upon any scientific data and thus are not justified. The proposed Guide also infringes on the scientific decision-making process of PHS grantees, contractors, and IRG's in a number of significant ways. For example, it would insist upon the use of "pharmaceutical grade" drugs used in animal experimentation. There is no data to support this recommendation. Furthermore, this will drive up costs unnecessarily, and it is not clear how one is supposed to make the appropriate concentrations needed for experiments and maintain the "pharmaceutical grade" status of the preparation. Similarly, the constraints proposed on multiple procedures in animals, multiple surgeries, new requirements for food- or fluid-restriction, uninformed and constraining sections on the choices of chemicals and other substances, and specific guidelines on "post-approval" monitoring are not justified by any data or scientific rationale. The bottomline is that this new Guide seems to be driven by an animal welfare agenda and not based upon scientific data. Please do NOT adopt this proposed Guide unless you want to drive up the cost of research and kill the majority of medical research in this country. Comment 2: This new guide needs to go back to the drawing board and any proposed changes need to be based upon scientific data or deleted from the guide. Thus, it is my esitmate that this can not be done in less than a year, and I would propose that you do not require the use of any new guide until this is done. I suggest you shoot for something like an implementation date of March 31, 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] 191 [Entry Date] 04/19/2011 at 02:45:48 PM [Affiliation] Self [Comments]

Output: Comment 1: I'm strongly opposed to the adoption of the 8th edition Guide. The new guidelines requires more floor space per mouse in a cage, which limits the number of mice can be held per cage. This will increase the amount of cages needed to hold the same amount of mice, and increases the total price each lab pays to maintain the cages. In my lab, it would be a 20% increase in cost, just to maintain the cages, not to mention the cost of having to buy the extra cages. In addition, female mice with litters would have to be housed individually, according to the new space requirements. This in turn could even triple the number of cages needed. For rats, the new space requirements would also mean one female and litter per cage, again leading to many more cages needing to be purchased. Some labs may not have the physical space required in their facility to house more cages, which would cost even more. I don't intend to sound greedy, as if this all has to do with money, but the money we have is best used towards our research, rather than accommodating new, scientifically unproven rules that may or may not support animal well being. The cost is too great for a benefit that is 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] 192 [Entry Date] 04/19/2011 at 02:46:53 PM [Affiliation] Organization [Organization Name] Wake Forest Baptist Health [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] 193 [Entry Date] 04/19/2011 at 02:47:02 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] 194 [Entry Date] 04/19/2011 at 02:49:15 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 195 [Entry Date] 04/19/2011 at 02:51:06 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] 196 [Entry Date] 04/19/2011 at 02:51:33 PM [Affiliation] Organization [Organization Name] Wake Forest University Health Sciences [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 197 [Entry Date] 04/19/2011 at 03:02:16 PM [Affiliation] Organization [Organization Name] Wake Forest School of Medicine [Organization City and State] Winston-Salem, NC [Comments]

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

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


Input: [ID] 198 [Entry Date] 04/19/2011 at 03:02:32 PM [Affiliation] Organization [Organization Name] Wake Forest 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, na?ve and constraining section on choices of ?chemicals and other substances? to give animals and specific guidance on ?post-approval? monitoring (e.g., observation of procedures). In addition the new ?Guide? requires an increased level of intra and post-operative surgical procedures Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

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


Input: [ID] 199 [Entry Date] 04/19/2011 at 03:03:54 PM [Affiliation] Organization [Organization Name] American College of Neuropsychopharmacology [Organization City and State] Brentwood, Tennessee [Comments]

Output: Comment 1: The American College of Neuropsychopharmacology (ACNP), founded in 1961, is the nation's premier professional society in brain, behavior, and psychopharmacology research. The field of neuropsychopharmacology involves the evaluation of the effects of natural and synthetic compounds upon the brain, mind, and human behavior. ACNP welcomes this opportunity to comment on the question of whether the recently published 8th edition of the "Guide for the Care and Use of Laboratory Animals" should supplant the 7th edition as Public Health Service (PHS) Policy to govern all PHS-Assured institutions. Although the 8th edition contains useful new information (e.g., on the care of aquatic species), it otherwise represents a significant departure from the 7th edition in ways that impose new constraints, paperwork burdens, and costs on investigators and institutions receiving federal funds for research without a concomitant increase in animal welfare. ACNP therefore supports the position of the National Association for Biomedical Research (NABR) in its letter to Francis Collins urging that the NIH not adopt the new Guide until and unless concerns regarding new regulatory burdens are addressed. Although there are numerous new requirements in the 8th edition of the Guide that would impose substantial new paperwork burdens and expense, ACNP will focus in its comments on one issue of particular concern for its members. The new section on "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" adds a policy that, on the surface, may sound reasonable, but is inappropriate for basic research. Its apparent premise (based on the citation of an interpretive rule guiding USDA inspectors regarding adequate veterinary care) that the use of commercial drug solutions sold for clinical use in human or veterinary practice "ensures that toxic and unwanted effects are not introduced into studies conducted with experimental animals" is false. 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 or concentrated in the laboratory to accomplish this purpose. In addition, many commercial formulations, such as those in pill or capsule form, contain filler material that could confound experimental effects, especially when used by alternative routes of administration. For ACNP members, the ultimate goal of neuropsychopharmacology research is to find new treatments for neuropsychiatric illnesses. A critical step in much of this research is to give drugs with novel mechanisms of action to laboratory animals. Most of these drugs are, by definition, unavailable from commercial sources and must be prepared by the investigator. The requirement in this new section of the Guide that "The use of non-pharmaceutical-grade chemicals or substances should be described and justified in the animal use protocol and be approved by the IACUC," inappropriately presumes the accuracy of the premise that any preparation of drug solutions by the researcher can be assumed to be inferior to commercial preparation. The further requirement that "In such instances, 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. . " inappropriately defers the scientific judgment of the researcher to the IACUC. This recommendation also presumes that the IACUC has expertise, or retains someone with such expertise, to evaluate the details of formulations planned by the researcher. Review of the Guide indicates that this new section uniquely micromanages pharmacological research. In conclusion, the section on "non-pharmaceutical grade drugs" and multiple other sections of the new Guide preempt scientific and professional judgment on the design and conduct of research. This section seems especially inappropriate for a document that will govern the research of scientists whose funding has been granted based to a significant degree on the peer-reviewed determination of their expertise and ability to carry out specialized research. It goes significantly beyond the traditional value of the Guide for setting standards for animal housing, husbandry, and veterinary care of research animals. Comment 2: ACNP 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] 200 [Entry Date] 04/19/2011 at 03:13:35 PM [Affiliation] Self [Comments]

Output: Comment 1: No, the Eighth edition ofthe Guide should not be adopted. This new guide was supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of what can only be called new "policy." Compliance with these new policy statements will increase the expense to institutions (e.g., changes in cage sizing) and expense to investigators (e.g., drugs). However, the scientific data justifying such changes is non-existent. The 2011 Guide will require a large increase in the paperwork burden (e.g., all deviations from "should" statements contained in the new Guide will now need to be justified). Adoption of the new guide may also negate the opportunity to diminish the regulatory burden resulting from reactions to issues for which institutions are already heavily regulated. Moreover, the new "Guide" policies constitute 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 institutions and to investigators 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" administered to to 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: The evaluation is to take place within one year of adoption of the new Guide. 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] 201 [Entry Date] 04/19/2011 at 03:24:00 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] 202 [Entry Date] 04/19/2011 at 03:25:36 PM [Affiliation] Self [Comments]

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

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


Input: [ID] 203 [Entry Date] 04/19/2011 at 03:36:37 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] 204 [Entry Date] 04/19/2011 at 03:37:37 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] 205 [Entry Date] 04/19/2011 at 03:45:14 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). 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] 206 [Entry Date] 04/19/2011 at 03:46:51 PM [Affiliation] Self [Organization Name] Wake Forest University Department of Physiology and Pharmacology [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] 207 [Entry Date] 04/19/2011 at 04:02:02 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] 208 [Entry Date] 04/19/2011 at 04:10:47 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] 209 [Entry Date] 04/19/2011 at 04:13:09 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, na?ve and constraining section on choices of ?chemicals and other substances? to give animals and specific guidance on ?post-approval? monitoring (e.g., observation of procedures). In addition the new ?Guide? requires an increased level of intra and post-operative surgical procedures. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. It is the data that should guide policy decisions.

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


Input: [ID] 210 [Entry Date] 04/19/2011 at 04:29:01 PM [Affiliation] Self [Comments]

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

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


Input: [ID] 211 [Entry Date] 04/19/2011 at 04:32:02 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] 212 [Entry Date] 04/19/2011 at 04:49:52 PM [Affiliation] Organization [Organization Name] Wake Forest University School of Medicine [Organization City and State] Winston-Salem, NC [Comments]

Output: Comment 1: The revised guide should not be adopted in its current form. The new guide was originally intended as 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] 213 [Entry Date] 04/19/2011 at 05:23:49 PM [Affiliation] Self [Comments]

Output: Comment 1: I vote NOT to adopt. The new Guide is nearly twice as long as the 1996 version, and contains a great deal of new policy that promises to significantly increase: (a) the expense of research to investigators and institutions with no real enhancement of animal welfare, (b) the paperwork burden on researchers, and (c) the authority of local IACUCs to restrict already peer-reviewed research. And while some of the new recommendations are based on empirical research, many are not (e.g., cage sizes, food & liquid restriction). Comment 2: For the deadline for full compliance if the new Guide is adopted, I recommend at least 4 years (e.g., 2015) before requiring investigator and institutional compliance, given the expense of a variety of cage size and housing requirements that are being required at a time of great financial difficulty for investigators and 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] 214 [Entry Date] 04/19/2011 at 05:27:16 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] 215 [Entry Date] 04/19/2011 at 05:32:56 PM [Affiliation] Self [Comments]

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

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


Input: [ID] 216 [Entry Date] 04/19/2011 at 05:34:07 PM [Affiliation] Organization [Organization Name] Wake forest baptist scoop of medicine [Organization City and State] Winston Salem [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] 217 [Entry Date] 04/19/2011 at 05:41:35 PM [Affiliation] Self [Comments]

Output: Comment 1: The new guide should not be adopted. Comment 2: At least 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] 218 [Entry Date] 04/19/2011 at 06:01:25 PM [Affiliation] Self [Organization Name] Johns Hopkins University [Organization City and State] Baltimore Maryland [Comments]

Output: Comment 1: I am an NIH-funded behavioral researcher and I am concerned by several aspects of the new Guide for the Care and Use of Laboratory Animals (new Guide) that I see as compromising scientific research with little if any demonstrated benefit for laboratory animal welfare. My concerns are that a) the new Guide contains recommendations that will, in effect, function like regulations, rather than guidelines for the care and use of research animals, b) the arecommendations are based on little scientific evidence in some cases, and c) the additional provisions will have a significant ecomomic impact on PHS-assured institutions. For these reasons, I believe the 1996 Guide should remain PHS policy and that the new Guide be used as a reference document. If the OLAW decides to adopt the new Guide as PHS policy, it should extend the unrealistic deadline from 2012. I believe 4-5 years would be necessary to full phase in the changes. Of significant concern to me are the increased cost and regulatory and paperwork burden, in terms of justifications, requests for exception, and additional recordkeeping that will occur if the new Guide is adopted. Much of this will result from recommendations that lack empirical evidence of enhanced laboratory animal welfare. Of particular concern are a) Housing - detailed specifications for cage sizing and recommended use of solid bottom cages particularly for rats and mice is based on weak to nonexistent evidence. Required social housing for all species does not recognize practical constraints on institutions; (b) IACUC responsibilities – new requirements for post-approval monitoring and formal review of "unexpected outcomes" will require additional staffing and recordkeeping; (c) Surgery -- the caution against multiple major survival surgical procedures not only increases costs because of the increase in number of animals required, but also interferes with the scientific integrity of the study by not allowing the use of within-subject and single subject designs that are particularly powerful for behavioral research; (d) Food/fluid regulation – a new requirement to keep written records of both daily food and fluid consumption for animals under either restriction precludes the use of commonly used automatic watering devices, even when water is not restricted. Further, the recommendation that "a highly preferred food or fluid be used as positive reinforcement, instead of restriction" for "conditioned-response research protocols" is made despite information provided in the cited papers that such strategies do not work well to train behaviors – one of many examples of guidance that is inappropriate, both scientifically and for ensuring appropriate use of laboratory animals; (e) Use of Non-Pharmaceutical Grade Chemicals and Other Substances – this new policy is based on false premises. For example, not only do very few commercially available preparations exist that are suitable as tools for experimental research but they are also subject to formulation errors. Also, in behavioral research with drugs, including studies such as those I conduct, the commercially available preparations would need to be altered (diluted to particular dose concentrations), increasing rather than decreasing the margin of error. I concur with the National Association for Biomedical Research (NABR) that the new Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB). Therefore, an opportunity for comment in greater detail from the research community on the substance of the new Guide and its financial consequences is necessary before a decision on the adoption of the new Guide as PHS Policy is made and an implementation strategy instituted. Comment 2: In my comments above I noted taht I think 2012 is unrealistic to fully implement the extensive set of recommendations listed in 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] 219 [Entry Date] 04/19/2011 at 06:50:05 PM [Affiliation] Self [Comments]

Output: Comment 1: I completely support the content of the draft letter that you have or will soon receive from NABR. I find the 2010 Guide to be detrimental to science, biomedical research and the nation's commitment to improving the health and well-being of its citizens and the citizens of the world. Although I cannot materially improve upon the excellent points made in the NABR letter, I would like to add one observation. Whereas the OLAW FAQ notes that deviations from recommended cage requirements be documented and based upon scientific or veterinary data, no such condition was applied to developing these cage recommendations in the first place.

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] 220 [Entry Date] 04/19/2011 at 06:59:45 PM [Affiliation] Self [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: Do not adopt. Retain the 1996 Guide. The revised 2011 Guide is nearly twice as long as the 1996 version, and contains a great deal of new policy that promises to significantly increase: (a) the expense of research, (b) the paperwork burden on researchers, and (c) and the authority of local IACUCs to restrict already peer-reviewed research. And while some of the new recommendations are based on empirical research, many are not (e.g., cage sizes, food & liquid restriction). Comment 2: Do not adopt. Retain the 1996 Guide. If necessary, I recommend at least 4 years (i.e., 2015) for transition to 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] 221 [Entry Date] 04/19/2011 at 07:07:35 PM [Affiliation] Self [Comments]

Output: Comment 1: Do not adopt these changes!!! No data is included that bigger cages are better or that pharmaceutical grade drugs give a better outcome. In the absence of this information- the proposed changes are simply 'thought experiments' that would significantly increase the administrative and financial burden on investigators, and restrict their ability to address valid experimental questions without any significant gain in animal welfare, experimental outcomes, or scientific knowledge. Animals used for research are already closely watched and all protocols are already evaluated by expert panels to ensure animal safety. The system is working- it does not need to be changed. Comment 2: Do not approve- but if so- implementation must be as long as possible- minimum of 4 years.

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] 222 [Entry Date] 04/19/2011 at 08:05:31 PM [Affiliation] Organization [Organization Name] LSUHSC School of Medicine [Organization City and State] New Orleans, LA [Comments]

Output: Comment 1: The whole scale adoption of the "Guide to the Care and Use of Laboratory Research" is an Extremely Bad idea for the future of medical research. The Guide's regulations are burdensome without benefit to animal welfare or science. Just a couple of specific points include: 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. Only pharmacuerical companies will benefit from these "Guide" restrictions.

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] 223 [Entry Date] 04/20/2011 at 03:16:37 AM [Affiliation] Self [Comments]

Output: Comment 1: I have only just been notified that a new Guide is available. I cannot comment on it in a few days. I think that a comprehensive synopsis of changes needs to be provided to all current NIH grant recipients who work with animals and an appropriate time available for comment prior to adoption of such a document.

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


Input: [ID] 224 [Entry Date] 04/20/2011 at 07:50:34 AM [Affiliation] Self [Comments]

Output: Comment 1: 1. On p. 83, 2 L of water for 1 adult X. laevis (especially females in production) is generally insufficient for routine housing; the traditional standard is actually 1 gallon (3.8L). We kept thousands of frogs and unless your filtration and water turnover systems, including organic skimming are on "operational steroids" or over-built, commercially sold housing systems at this density will lead to stress, disease (e. g. atypical Mycobacterium), and increased mortality. This is the standard that people who sell the equipment list to tout its virtues (because other designs can pack higher densities), but it is insufficient as a routine, especially when high growth rates and colony production are the goal, which is usually the case. 2. p 84. Use of latex gloves is toxic to larvae... If you read the 2 publications from that period, my recollection is that you will find that in addition to latex, nitrile and some batches of vinyl are also toxic! Wiping or rinsing before use in water, especially if talc or starch are present are best practices. 3. p 84-85. I can attest that live food should be avoided except where necessary (e. g. only food an animal will eat, and then only until one can get it on a complete artificial diet, if possible) because live commercial source food carried multiple atypical mycobacterium by PCR (16s and heat shock protein genes, etc.)and this in turn led to diseased frogs with considerably higher morbidity and mortality. Live prey should be considered at high risk of spreading disease, and some note of caution should be included here. You mention the health of the prey, but the Mycobacterium was a likely commensal, and prey can look healthy even when diseased. This is well known from fish culture and for other exotic species as well.

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] 225 [Entry Date] 04/20/2011 at 08:47:15 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