Input: [ID] 409 [Entry Date] 04/22/2011 at 10:14:20 AM [Affiliation] Self [Comments]

Output: Comment 1: As an investigator at a primarily undergraduate institution, I have serious concerns about the new restrictions and costs that adopting the new Guide will impose upon researchers. This guide was clearly intended for large, research-first institutions that have many animal colonies overseen by professional staff, and that have adequate institutional or grant funding to incur additional administrative costs. Of particular concern to me is that these guidelines will make it prohibitively difficult for smaller institutions to establish and maintain quality research facilities. Many thousands of research laboratories exist at such institutions, and they are often capably staffed by the investigators themselves, not a professional staff. The animals under such care are not "warehoused" as they may be at other institutions, and receive careful, humane treatment and care under the current guidelines. The additional guidelines in the new version of The Guide will not change animal care at such institutions, but will mandate additional costs that could jeapordize the willingness of administration to have animal colonies on campus. Is there data to indicate that the Guide needs changing? What is that data? If the guide is adopted, it could mean the end of research for many investigators, thus taking away the opportunites for undergraduate students who want to pursue a career in the biomedical sciences. My fear is that the additional costs and paperwork required by the new guide will be unduly burdensome, especially for those institutions that teach undergraduates and have limited funds. Comment 2: The additional burdens placed on researchers and institutions by implementing this guide could mean the end of research for many investigators, especially at smaller, primarily undergraduate institutions where support for animal research facilities is not as strong as "research-first" institutions. This would mean taking away the opportunites for undergraduate students interested in the biomedical sciences. My fear is that the additional costs and paperwork required by the new guide will be unduly burdensome, especially for those institutions that teach undergraduates and have limited funds.

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


Input: [ID] 410 [Entry Date] 04/22/2011 at 10:18:51 AM [Affiliation] Self [Comments]

Output: Comment 1: I am opposed to adopting this. This new edition of the Guide includes a large number of new regulations which will impede laboratory research. Very little empirical evidence has been provided that show any sort of cost benefit analysis supporting these new policies. I would expect NIH to base their decisions on a careful consideration of the costs to grantees and their institutions as well as the possible benefits to animal welfare. Comment 2: Providing less than one year to implement this is unrealistic and does not allow enough time to evaluate its financial impact.

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] 411 [Entry Date] 04/22/2011 at 10:32:28 AM [Affiliation] Self [Organization Name] Virginia Commonwealth University [Organization City and State] Richmond, VA 23298 [Comments]

Output: Comment 1: Many of the "guidelines," which usually end up becoming mandates by regulatory bodies, interfere with the conduct of research without enhancing or even harming the well-being of the animal subjects. Two examples follow: Page 56: "Floor space taken up by food bowls, water containers, litter boxes, and enrichment devices (e.g., novel objects, toys, foraging devices) should not be considered part of the floor space." This does not into consideration that the animal can walk or climb on or through the enrichment device or carry it around (paper cups, cardboard tubes). These new standards could greatly restrict research where space is at a premium and will require employing personnel who police this. Page 119: "Careful monitoring increases the likelihood of successful surgical outcomes (Kuhlman, 2008). Monitoring includes routine evaluation of anesthetic depth and physiologic functions and conditions, such as body temperature, cardiac and respiratory rates and pattern (Flegal et al. 2009), and blood pressure (Kuhlman 2008), and should be appropriately documented." I completely disagree with this statement. In rodents, successful surgical outcomes are best assured by clean, efficient surgeries that do not require supplemental anesthetic or longer exposure to gas anesthesia than necessary. Not only is it difficult to measure these physiological signs in rodents, doing so requires distraction from the surgery that increases anesthetic exposure and encourages break from aseptic technique. In surgeries involving pregnant or immature rodents it is especially important to limit the duration of the surgical procedure, as this will limit the overall exposure of the immature brain to anesthetic agents, which are known to adversely impact the developing nervous system (for a review, see Wang and Slikker, Anesthesia and Analgesia, 106: 1643, 2008).

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] 412 [Entry Date] 04/22/2011 at 11:01:51 AM [Affiliation] Organization [Organization Name] CPDD [Organization City and State] Bridgewater, NJ [Comments]

Output: Comment 1: The College on Problems of Drug Dependence (CPDD) is the oldest U.S. scientific society on drug dependence. Originally founded in 1929 as part of the National Academy of Sciences, CPDD now is an independent scientific society comprised of ???? members.. It serves researchers, clinicians, and policy makers to promote research and facilitate the transfer of findings to improve drug abuse treatment and prevention practices. CPDD welcomes the opportunity to comment on whether the 8th edition of the "Guide for the Care and Use of Laboratory Animals" should supplant the 7th edition as PHS Policy. CPDD recommends that the 8th edition not be adopted as PHS Policy. While it contains some useful new information (e.g., on care of aquatic species), there are numerous problems with the 8th edition as federal policy that will govern PHS-funded researchers. Instead, the 8th edition can function, as do other National Academy publications, as a useful reference volume on certain issues relating to animal husbandry. The 8th edition departs significantly from the 7th,,which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. Many of these will result in higher costs to grants and to institutions. Mandatory requirements for new cage sizes for some species (particularly rodent breeding) and for social housing of all species will require large expenditures. Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" are examples of items requiring additional IACUC staffing and researcher effort. A major change in the Guide is the introduction of language cautioning against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries. This echoes a newly introduced caution against animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. These restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral research. Further, the Guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." The section on "Food and Fluid Regulation" requires daily recording of food and fluid consumption for all animals on either type of restriction, which ignores the fact that animals for which one commodity is restricted have unrestricted access to the other. This requirement will necessitate use of calibrated water bottles or flow-meters rather than the now common automated watering systems, thus incurring additional equipment costs; and will require a method of weighing the unrestricted food given to fluid-restricted animals. Guidance to use "treats" for behavioral training with the assumption that this avoids food restriction is counter to the information in two of the scholarly reviews cited in that same Guide paragraph. These examples may represent only imprecise drafting, rather than intent, but this is only one example of how the 8th edition is unsuitable as federal policy. The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from using standard source drugs for research,(e.g., compounds from the NIDA drug supply program; reliable private vendors; chemists) or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. It also is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. Even the intramural Policy ignores that the NIDA drug supply program and other standard sources do not prepare to USP standards, as these have more to do with documenting drug manufacture than drug quality. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the new Guide's intrusion into the realm of the scientific and professional judgment of NIH-funded researchers. Comment 2: CPDD concurs with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 413 [Entry Date] 04/22/2011 at 11:26:54 AM [Affiliation] Organization [Organization Name] McLean Hospital [Organization City and State] Belmont, MA [Comments]

Output: Comment 1: NIH should not adopt the eighth edition of the Guide for the Care and Use of Laboratory Animals . 1 VOTE NO. There are many reasons not to approve this Guide, here are some: 1. Increased economic cost to the scientists and to the institution 2. Increased administrative cost in terms of additional burdensome paperwork 3. Increased costs if pharmaceutical-grade drugs are required 4. Increased costs and injury to animals if the proposal to require social housing for nonhuman primates is required 5. The constraints on conducting multiple procedures in animals and a requirement for "post-approval monitoring" of procedures Comment 2: NIH should not implement a plan requiring institutions to complete semiannual programs using the eighth edition of the Guide for at least five (5) 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] 414 [Entry Date] 04/22/2011 at 11:45:59 AM [Affiliation] Self [Organization City and State] Springfield, MA [Comments]

Output: Comment 1: I oppose additional restrictions on cage size and liquid or food deprivation of laboratory animals. The costs incurred from compliance with these changes will severely impair the ability of researchers to continue their critical work in the areas of behavioral pharmacology, neuroscience, and basic behavioral processes. As an applied researcher, I am certain that a decrease in non-human research will also eventually affect the quality and pace of research conducted by me and my colleagues. The trickle-down implications of these cost-prohibitive regulations cannot be understated. Comment 2: I think that semiannual review of revised guidelines would be reasonable. However, if the full Guide is ultimately accepted, I would support a deadline for compliance no earlier than 2015 to avoid disrupting or derailing critical research.

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


Input: [ID] 415 [Entry Date] 04/22/2011 at 12:08:10 PM [Affiliation] Self [Comments]

Output: Comment 1: My particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. Many of these will result in higher costs to grants and to institutions. A major change in the Guide is the introduction of language cautioning against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries. This echoes a newly introduced caution against animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. These restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral research. Further, the Guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." The section on "Food and Fluid Regulation" requires daily recording of food and fluid consumption for all animals on either type of restriction, which ignores the fact that animals for which one commodity is restricted have unrestricted access to the other. This requirement will necessitate use of calibrated water bottles or flow-meters rather than the now common automated watering systems, thus incurring additional equipment costs; and will require a method of weighing the unrestricted food given to fluid-restricted animals. Guidance to use "treats" for behavioral training with the assumption that this avoids food restriction is counter to the information in two of the scholarly reviews cited in that same Guide paragraph. These examples may represent only imprecise drafting, rather than intent, but this is only one example of how the 8th edition is unsuitable as federal policy. The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from using standard source drugs for research,(e.g., compounds from the NIDA drug supply program; reliable private vendors; chemists) or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. It also is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. Even the intramural Policy ignores that the NIDA drug supply program and other standard sources do not prepare to USP standards, as these have more to do with documenting drug manufacture than drug quality. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the new Guide's intrusion into the realm of the scientific and professional judgment of NIH-funded researchers. Comment 2: I concur with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 416 [Entry Date] 04/22/2011 at 12:09:00 PM [Affiliation] Self [Comments]

Output: Comment 1: I am against the adoption of the new edition of the Guide. The 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echos a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Comment 2: I am against the adoption of the new edition of the Guide. 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, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 417 [Entry Date] 04/22/2011 at 12:09:10 PM [Affiliation] Organization [Organization Name] UCSD [Organization City and State] San Diego, CA [Comments]

Output: Comment 1: I appreciate the opportunity to comment on whether the 8th edition of the "Guide for the Care and Use of Laboratory Animals" should supplant the 7th edition as PHS Policy to govern research at PHS-Assured institutions. I beleive that there is not adequate justification for supplanting the 1996 Guide as PHS Policy and that there are numerous problems with the new Guide as federal policy. Our comparison of the 7th and 8th editions lead us to conclude that the 8th edition represents a significant departure from the 7th. Although it includes much new information, it also incorporates new policies in a number of areas. Of particular concern is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echos a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Although OLAW has published a similar set of statements on its website in recent years, the status as enforceable PHS Policy has been controversial due to their de novo introduction of the topic as an answer to a "Frequently Asked Question," (i.e., no previously published PHS Policy nor the Guide had addressed use of drugs in research). No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of, first, the USDA/APHIS Policy 3, an interpretive rule for use of pharmaceutical grade "medications" to prevent pain/distress in the conduct of research; and second, the NIH policy for its intramural program on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement has made clear that Policy 3 is interpreted to require use of commercially prepared solutions, rather than those prepared by investigators; the first sentence of the new Guide section on this topic is consistent with this view. Yet the NIH policy defines "pharmaceutical grade" drugs as those manufactured according to USP standards, thus accommodating the practice of preparation of drug solutions in the laboratory. Yet even that intramural NIH Policy ignores the fact that the NIDA drug supply program, which has been operating to supply compounds to funded researchers for decades, does not prepare to USP standards, because they are unnecessary for research purposes. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Yet, as with other sections, the contradictions in guidance were not recognized by those who published the 2011 Guide. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify their use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the intrusion of the new Guide into second-guessing scientific and professional judgment of experts in their fields of research. This represents only one of many examples of greater burdens on the IACUC, and by extension staff, imposed by new requirements. Comment 2: CPDD 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, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 418 [Entry Date] 04/22/2011 at 12:18:33 PM [Affiliation] Organization [Organization Name] Johns Hopkins University [Organization City and State] Baltimore, MD [Comments]

Output: Comment 1: The Johns Hopkins University appreciates the opportunity to offer comments on the 8th edition of the Guide for the Care and Use of Laboratory Animals. We applaud the efforts of the ILAR revision committee that has expanded and updated the previous edition of The Guide. 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 unjustified new constraints on research design, new paperwork burdens, and new costs (for both equipment and personnel) on institutions receiving federal funds for research. We believe these significant changes come without a concomitant increase in animal welfare and will therefore diminish the quality of essential biomedical research. Johns Hopkins University 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 through evaluation of the 8th edition of the Guide as a "significant guidance document under the Office of Management and Budget's Bulletin No. 07-02, "Final Bulletin for Agency Good Guidance Practices." Comment 2: The Johns Hopkins University 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 on the National Institutes of Health 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] 419 [Entry Date] 04/22/2011 at 12:35:13 PM [Affiliation] Self [Comments]

Output: Comment 1: I am quite concerned about the proposed increases in required cage sizes. I sit on a university committee related to animal use, and can say from that experience that space allocation for animal research is a huge concern. As I'm sure is true for many other institutions, we include additional vivarium space with any new building project to stay ahead of demand. However, the new space would be woefully inadequate to address the new standards. Further, all institutions are heavily invested in caging. Replacement of current caging systems would require an enormous amount of funding. It seems to me the justification given for these new requirements is insufficient, considering their impact. Comment 2: I can't imagine that institutions could possibly put into effect the changes that this program would require in less than a year's time. Further, I would hope the regulations will be significantly revised before they must be used by anyone.

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] 420 [Entry Date] 04/22/2011 at 12:37:50 PM [Affiliation] Self [Comments]

Output: Comment 1: The College on Problems of Drug Dependence (CPDD) is the oldest U.S. organization concerned with drug dependence research. Originally founded in 1929 as part of the National Academy of Sciences, CPDD is an independent, leading scientific society in the drug dependence field. It serves researchers, clinicians, and policy makers to promote understanding of the many facets of drug abuse to the benefit of all involved in drug and alcohol research and to facilitate the transfer of scientific findings to successful treatment and prevention practices. CPDD welcomes this opportunity to comment on whether the 8th edition of the "Guide for the Care and Use of Laboratory Animals" should supplant the 7th edition as PHS Policy to govern research at PHS-Assured institutions. CPDD's conclusion is that there is not adequate justification for supplanting the 1996 Guide as PHS Policy and that there are numerous problems with the new Guide as federal policy. Our comparison of the 7th and 8th editions lead us to conclude that the 8th edition represents a significant departure from the 7th. Although it includes much new information, it also incorporates new policies in a number of areas. Of particular concern to CPDD is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echos a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Although OLAW has published a similar set of statements on its website in recent years, the status as enforceable PHS Policy has been controversial due to their de novo introduction of the topic as an answer to a "Frequently Asked Question," (i.e., no previously published PHS Policy nor the Guide had addressed use of drugs in research). No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of, first, the USDA/APHIS Policy 3, an interpretive rule for use of pharmaceutical grade "medications" to prevent pain/distress in the conduct of research; and second, the NIH policy for its intramural program on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement has made clear that Policy 3 is interpreted to require use of commercially prepared solutions, rather than those prepared by investigators; the first sentence of the new Guide section on this topic is consistent with this view. Yet the NIH policy defines "pharmaceutical grade" drugs as those manufactured according to USP standards, thus accommodating the practice of preparation of drug solutions in the laboratory. Yet even that intramural NIH Policy ignores the fact that the NIDA drug supply program, which has been operating to supply compounds to funded researchers for decades, does not prepare to USP standards, because they are unnecessary for research purposes. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Yet, as with other sections, the contradictions in guidance were not recognized by those who published the 2011 Guide. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify their use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the intrusion of the new Guide into second-guessing scientific and professional judgment of experts in their fields of research. This represents only one of many examples of greater burdens on the IACUC, and by extension staff, imposed by new requirements. Comment 2: CPDD 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, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 421 [Entry Date] 04/22/2011 at 12:56:28 PM [Affiliation] Self [Organization Name] New York State Psychiatric Insitute [Organization City and State] New York, NY [Comments]

Output: Comment 1: As chair of an IACUC at a large New York State research facility, I recommend that the 8th edition not be adopted as PHS Policy. There are numerous problems with the 8th edition as federal policy that will govern PHS-funded researchers. In addition the guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." Never-the-less, the 8th edition can function, as do other National Academy publications, as a useful reference volume on certain issues relating to animal husbandry. The 8th edition departs significantly from the 7th,, which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition; policies that must be followed. The excessive use of the "must" term removes the traditional role of the IACUC in supervising animal work in accordance with locally-based knowledge of the complexities attendant to the specific types of research being conducted at an institution. Thus, the new policies constrain the exercise of scientific and professional judgment. Further any local variation away from the "must" list will entail massive amounts of tedious paperwork that will cost much in time and money and do nothing to improve animal welfare. Higher costs to institutions (not counting the time donated by IACUC members) will have to be passed on to grants through increased direct and indirect costs. What is challenging for scientists working with laboratory animals is the absence of data supported so many of the "must." Data we can work with, hunches and feelings that a change is good is a different matter entirely. I will focus on only a few specific concerns. 1) Mandatory requirements for new cage sizes for some species and for social housing of all species will require large expenditures. The increase in cage size for rodent breeding, based on no data, is particularly troubling. Our institution is modest with about 20,000 rodents but breeding is key especially for mouse work and the increased cost will decrease funding for the science part of the work. 2) Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") places a great burden on the IACUC and its members. Our current PAM practices address adequately address the issues, but the addition more specific review points is a burden. Likely the extra work will entail increasing IACUC size and staff. 3) The language cautioning against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries ignores both studies that are best done with multiple survival surgeries and long-term studies that based on their length may require motile surgeries. Further restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. Finally, these restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral and psychiatric research. 4) The section on "Food and Fluid Regulation" now requires daily recording of food and fluid consumption for all animals on either type of restriction will increase burden without improving animal care. This requirement will necessitate use of calibrated water bottles or flow-meters rather than the now common automated watering systems, thus incurring additional equipment costs; and will require a method of weighing the unrestricted food given to fluid-restricted animals. Guidance to use "treats" for behavioral training with the assumption that this avoids food restriction is counter to the information in two of the scholarly reviews cited in that same Guide paragraph. These examples may represent only imprecise drafting, rather than intent, but this is only one example of how the 8th edition is unsuitable as federal policy. 5) The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" shows a complete lack of understanding research examining drug effects on behavior and studies that manipulate internal states with drugs as pharmacological probes of underlying mechanism. This section essentially bans researchers from using standard source drugs for research including compounds from the National Institute on Drug Abuse drug supply program; reliable private vendors; chemists or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. It also is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the new Guide's intrusion into the realm of the scientific and professional judgment of NIH-funded researchers. Again this is an intrusion into the scientific process without any data justifying the change. An issue not directly addressed by focusing on the human and financial burden of the new guide is the fact that increasing costs for housing and breeding will decrease money available for the science part of the project. An increase in both direct and indirect costs will decrease funds available to support investigators. Those hurt the most will be junior investigators just getting their careers started. This will put an entire generation of scientists at risk. This is not a minor issue. Recent cutbacks have already significantly disheartened the latest batch of individuals looking for their first research award at my institution. Further cut backs will be devastating in both the short and long terms for progress in medical and psychological science. Comment 2: I agree with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made. As chairman of my IACUC I can say with certainty that we will not be prepared to meet the new proposed standards if adopted in such a brief time frame. Physical space and financial restraints would make it impossible. Further the greater demands placed on IACUC membership will make serving on the IACUC an even greater strain on the ability to conduct one's own research and keep one's own funding tenable. I care deeply about the science our researchers conduct and in the proper care of our laboratory animals. What I've seen in the new guide will not improve substantially our animal care but will impede science.

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


Input: [ID] 422 [Entry Date] 04/22/2011 at 01:29:43 PM [Affiliation] Self [Comments]

Output: Comment 1: No, the eighth edition of the Guide should not be adopted. Many of the changes are unnecessary. Several of the revisions are inconsistent with high quality rodent behavior experiments. Several of the new requirements create additional paperwork that does not add to the quality of animal care and use.

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] 423 [Entry Date] 04/22/2011 at 01:54:32 PM [Affiliation] Organization [Organization Name] University of Texas at El Paso [Organization City and State] El Paso, Texas [Comments]

Output: Comment 1: The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from using standard source drugs for research,(e.g., compounds from the NIDA drug supply program; reliable private vendors; chemists) or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. There are several problems with this request. First, there is a lack of a definition of pharmaceutical grade. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review. Second, it is unclear that this provision will be an improvement over currently used practices. Given that it is a costly suggestion, I worry that a careful cost/benefit analysis has not been done. I personally contacted Sigma INC on this matter when our last veterinarian was encouraging us to purchase Nembutal, over pentobarbitol which wee were purchasing from Sigma. When I called Sigma, they were unclear what this definition meant, especially given that they are a pharmaceutical company. They did describe the careful provisions that they took to ensure the quality of their compounds. They also save portions of lots of their drugs to enable them to go back and re-evaluate the purity of lots. Related to this, is cost and whether it is a valuable use of our research dollars. As an example, a vial of nembutal (or animal sacrifice) is at least 5 times the cost of the same drug that can be purchased and prepared in our own laboratories---using pure compounds purchased from well known pharma compainies. This seems to be an unwarranted request that is difficult to accept given the cuts in NIH funding that we are all experiencing. On a final note, the 8th edition departs significantly from the 7th, which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. They require additional staffing and or time from researchers who want to stay focused on advancing science while still taking quality care of research animals. Many of these will result in higher costs to grants and to institutions, and importantly, it is not clear that the changes will improve the quality of the animals lives and of the research findings. Comment 2: It is unclear whether this revision will improve the quality of animal research over what is currently done. These provisions are potentially costly in money and time and require additional staffing that many institutions cannot afford. A more careful cost/benefit analysis is needed to ensure that this major change is truly warranted.

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] 424 [Entry Date] 04/22/2011 at 01:56:31 PM [Affiliation] Self [Organization Name] McLean Hospital [Organization City and State] Belmont, MA [Comments]

Output: Comment 1: The 8th edition departs significantly from the 7th,,which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. Many of these will result in higher costs to grants and to institutions. The requirement for pair/group housing of nonhuman primates is logistically and economically unfeasible for many facilities. It will be prohibitively expensive for many programs to completely redesign and replace their entire animal housing set-up to accommodate this rule. IACUC committees will subsequently be confronted with the unenviable choice of granting broad exemptions or imposing unreasonable economic and labor burdens on investigators. Additionally, this requirement will pose increased health risk to animals including injuries and disease transmission as well as additional risks to staff. Mandatory requirements for new cage sizes for some species (particularly rodent breeding) and for social housing of all species will require large expenditures. Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" are examples of items requiring additional IACUC staffing and researcher effort. A major change in the Guide is the introduction of language cautioning against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries. This echoes a newly introduced caution against animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. These restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral research. Further, the Guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." The section on "Food and Fluid Regulation" requires daily recording of food and fluid consumption for all animals on either type of restriction, which ignores the fact that animals for which one commodity is restricted have unrestricted access to the other. This requirement will necessitate use of calibrated water bottles or flow-meters rather than the now common automated watering systems, thus incurring additional equipment costs; and will require a method of weighing the unrestricted food given to fluid-restricted animals. Guidance to use "treats" for behavioral training with the assumption that this avoids food restriction is counter to the information in two of the scholarly reviews cited in that same Guide paragraph. These examples may represent only imprecise drafting, rather than intent, but this is only one example of how the 8th edition is unsuitable as federal policy. The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from using standard source drugs for research,(e.g., compounds from the NIDA drug supply program; reliable private vendors; chemists) or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. It also is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. Even the intramural Policy ignores that the NIDA drug supply program and other standard sources do not prepare to USP standards, as these have more to do with documenting drug manufacture than drug quality. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the new Guide's intrusion into the realm of the scientific and professional judgment of NIH-funded researchers. Comment 2: I concur 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, an opportunity for a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 425 [Entry Date] 04/22/2011 at 02:18:42 PM [Affiliation] Organization [Organization Name] Johns Hopkins University School of Medicine [Organization City and State] Baltimore, MD [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. For example, 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; and 3) The regulation is burdensome without benefit to animal welfare or science. Adherence to the 2011 Guide will require a large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies 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] 426 [Entry Date] 04/22/2011 at 02:20:41 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] 427 [Entry Date] 04/22/2011 at 02:20:44 PM [Affiliation] Self [Comments]

Output: Comment 1: Bad idea. Comment 2: Bad idea with this guide.

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


Input: [ID] 428 [Entry Date] 04/22/2011 at 02:22:16 PM [Affiliation] Self [Comments]

Output: Comment 1: There are no valid data justifying the benefits and expense of the proposed eighth edition changes. Adoption would be costly and burdensome to the scientific community. Comment 2: No action should be taken until thorough study of the need and justification for changing exiting guidelines.

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


Input: [ID] 429 [Entry Date] 04/22/2011 at 02:29:33 PM [Affiliation] Organization [Organization Name] The American Association of Immunologists [Organization City and State] Bethesda, Maryland [Comments]

Output: Comment 1: The American Association of Immunologists (AAI), a professional association of more than 7,200 of the world's leading research scientists and physicians who are dedicated to elucidating the immune system through basic research, appreciates having this opportunity to express its views on whether the NIH Office of Laboratory Animal Welfare (OLAW) should adopt the recently published 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide). In their research, AAI members use and depend on rodents, and in particular laboratory mice, and therefore have a deep interest in all matters governing their care and use. Although AAI recognizes, and agrees with, the goal of updating the former Guide – to ensure the humane care of laboratory animals – AAI believes that the revised Guide will have a substantial negative impact on NIH-funded biomedical research. AAI is confident that the Guide can be updated in a way that addresses the humane care of animals, a goal which we strongly endorse, without unnecessarily or inadvertently reducing scientific research capacity or disrupting, impeding, or burdening the research scientists who spend their careers in search of answers and cures. Unfortunately, the revised Guide does not accomplish this objective. As a result, AAI urges OLAW not to adopt or implement the 8th edition of the Guide. AAI is aware that OLAW has received comments regarding the adoption of the 8th edition of the Guide from the National Association for Biomedical Research (NABR). AAI wholly endorses NABR's comments and shares its substantive concerns. AAI underscores the following points of major concern: 1) The new Guide has not been sufficiently vetted by the scientific community it is meant to serve. The new Guide is a quantum change from the previous version. The AAI community is one of many that looked forward to a new, modernized Guide that balances the needs of laboratory experimentation with humane animal care. However, the new Guide falls far short of our expectations: in too many cases changes have been mandated without scientific justification. And too often, the new Guide makes generalizations and creates ambiguities both in lines of responsibility and logical application to specific laboratory organisms. AAI will not address specific granular concerns in this solicitation for Public Comment, but AAI would be happy to comment in greater detail at a later date or to meet with OLAW to discuss our detailed concerns. The impact of these concerns is magnified because some language in the new Guide might be construed to prohibit the use of animals in certain experiments that are currently considered humane. Moreover, AAI does not believe that these problems can be solved by OLAW's publication of its interpretation of the new Guide via FAQs. Instead, the problem is with the new Guide itself because reasonable interpretations in the FAQs could, at best, confuse matters further, and at worst, directly contradict what is written in the Guide. 2) New rodent cage space restrictions are not based on substantiated scientific data. The new restrictive cage space policy, unjustified by scientific data, would have far-reaching scientific and financial impact on a breath of Public Health Service supported biomedical research. A strict interpretation of the new Guide would have tremendous adverse effect and appears to be inconsistent with best, healthy breeding practices. For example, duo (1 male and 1 female) and trio (one male and 2 females) of laboratory mice within the recommendations of the 7th Guide are shown by years of experience to be the most beneficial configurations for litters to survive and thrive. There are no substantiated data that merit a change from the former time-tested policy. This new policy, if adopted, would require a doubling to tripling of breeding colony to even approach the same productivity. It would also require the dismantlement of caging systems, including racks, designed to comply with the 7th Guide recommendations, and would cost hundreds of millions of dollars and time lost to retrofit caging systems and to expand current animal facilities (including continually incurring husbandry costs). The impact of this scientifically unjustified change is far-reaching because it would not only negatively impact organizations that perform rodent breeding but also drive up the costs for all organizations that purchase laboratory rodents to an unsustainable level. Most importantly, this new restrictive policy is inconsistent with data from multiple peer-reviewed publications evaluating the effects of cage density. Furthermore, data in peer-reviewed papers published since the 7th edition show that a number of common mouse strains can be housed at twice the density recommended by 7th edition of the Guide, in some cases with apparent benefits to health. Therefore, it is troubling from both animal health and financial perspectives that maximum recommended caging densities were not relaxed to reflect this new information. In conclusion, AAI urges OLAW not to adopt or implement the 8th edition of the Guide until it has been revised, following the solicitation of detailed comments by the scientific community and after careful consideration of the concerns that working scientists have raised. AAI respectfully requests that in the meantime, OLAW continue to use and rely upon the 7th edition of the Guide. Comment 2: Because AAI urges OLAW not to adopt or implement the 8th edition of the Guide until it has been revised, following the solicitation of detailed comments by the scientific community and after careful consideration of the concerns that working scientists have raised, AAI does not support NIH's proposed implementation plan. If NIH does adopt the 8th edition of the Guide, despite the many concerns raised, AAI recommends that NIH delay implementation at least until March 31, 2013, except for life- threatening issues (e.g., cage washer safety).

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] 430 [Entry Date] 04/22/2011 at 02:34:07 PM [Affiliation] Self [Comments]

Output: Comment 1: My vote is for OLAW to retain the 1996 Guide as PHS policy. I am a basic research scientist who studies the behavior of rats in laboratory conditions. My research has been continuously funded by NIH and/or NSF from 1957-2010. I have been a member of our University's IACUC committee, editor or consulting editor of journals with articles on animal behavior, and served as a member of several grant review committees of NIH and NSF related to animal behavior. My concern is that I knew nothing about the Eighth Edition of the Guide for the Care and Use of Laboratory Animals until today when a colleague asked me to look at it on Friday afternoon, and comment on it by one minute before midnight on Sunday. I was struck by the enormity of the task--this is a large revision with many apparently small modifications with large potential ramifications. Every semester I teach an advanced undergraduate research course on the behavior of rats, and I currently have three other IACUC protocols. I interact with veterinarians, animal caretakers, administrators responsible for animals, and animal researchers. If I did not know about the plan to adopt these changes, I assume that many others did not know either. This could be a serious problem. The new Guide for the Care and Use of Laboratory Animals should be used as a "Guide" for the next four years. We should have real experience in these guidelines before the words are given the status of rules.

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] 431 [Entry Date] 04/22/2011 at 02:39:41 PM [Affiliation] Self [Comments]

Output: Comment 1: No. I do not favor adoption of the revised Guide. 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] 432 [Entry Date] 04/22/2011 at 02:45:06 PM [Affiliation] Self [Comments]

Output: Comment 1: NO Comment 2: NO

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


Input: [ID] 433 [Entry Date] 04/22/2011 at 02:47:03 PM [Affiliation] Self [Comments]

Output: Comment 1: No Comment 2: No

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


Input: [ID] 434 [Entry Date] 04/22/2011 at 02:52:19 PM [Affiliation] Self [Comments]

Output: Comment 1: The NIH should NOT adopt this "revised" (8th edition) report. It contains many changes that will impede scientific inquiry and progress as well as increase costs in conducting research. Most importantly, there is no evidence provided that many of the indicates changes (e.g., cage size) will, in fact, have any effect on animal welfare per se. Comment 2: It seems premature to require institutional IACUC semiannual evaluations to be based on this 8th edition at this time.

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


Input: [ID] 435 [Entry Date] 04/22/2011 at 03:00:37 PM [Affiliation] Self [Comments]

Output: Comment 1: I strongly oppose adoption of the new Guide for the Care and Use of Laboratory Animals as the 8th edition. The new guide has doubled in size. There is no need for additional rules and regulations. Animal care is already overly regulated. In particular, I cite the following issues as poorly thought out. Several will require enormous added expense and result in no increase in animal welfare. 1. I am opposed to the new mandatory requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species. Implementation of these requirements will require large expenditures of funds to accomplish. 2. I oppose the newly introduced requirements for post-approval monitoring of IACUC-approved protocols and formal review of "unexpected outcomes" of research. Such requirements are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members and are unnecessary. 3. I oppose the new requirement that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems. This is only one example of guidance that is inappropriate. 4. I oppose the newly added section titled "Use of Non-Pharmaceutical Grade Chemicals and Other Substances". This section is particularly problematic because it essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Comment 2: I believe that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 436 [Entry Date] 04/22/2011 at 03:02:13 PM [Affiliation] Self [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: The 8th edition departs significantly from the 7th,,which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. Many of these will result in higher costs to grants and to institutions. I am against adopting the the 8th addition of the Guide. Comment 2: The 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.

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


Input: [ID] 437 [Entry Date] 04/22/2011 at 03:06:41 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. The new Guide includes, without providing clear justifications, many changes that will increase cost of animal research. These costs will slow or stop research. It appears that many of the new changes reflect opinions rather than actual data about what benefits animal subjects. By imposing arbitrary guidance requirements, the changes also diminish the ability of local institutions to ensure adequate welfare. Comment 2: Data are needed to guide policy decisions. OLAW should require institutions to comply with a new Guide no earlier than May 2015 (or three years after the date that this comment period closes, whichever comes later), in order to allow NIH and other organizations to acquire and analyze data relevant to any regulatory additions placed in the Guide.

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


Input: [ID] 438 [Entry Date] 04/22/2011 at 03:10:31 PM [Affiliation] Self [Comments]

Output: Comment 1: NO. Opposed.

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] 439 [Entry Date] 04/22/2011 at 03:14:16 PM [Affiliation] Organization [Organization Name] Columbia University [Organization City and State] New York, NY [Comments]

Output: Comment 1: I oppose approval of the new guide. Comment 2: I oppose using the new guide for IACUC inspections.

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] 440 [Entry Date] 04/22/2011 at 03:24:12 PM [Affiliation] Self [Comments]

Output: Comment 1: No. This new edition creates unnecessary and costly restraints for animal research taht will harm science and patients through impeding critical work leading to new drugs and treatments.

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] 441 [Entry Date] 04/22/2011 at 03:29:03 PM [Affiliation] Organization [Organization Name] University of California, San Diego [Organization City and State] La Jolla, CA [Comments]

Output: Comment 1: The eighth edition of the Guide should not be approved. It creates unnecessary and unsubstantiated changes in animal care that will be deleterious to research activities.

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] 442 [Entry Date] 04/22/2011 at 03:58:42 PM [Affiliation] Self [Organization City and State] St. Davids, PA. 19087 [Comments]

Output: Comment 1: I do not believe this 8th edition should be adopted. It may create barriers to much-needed animal research...while significantly increasing research costs and bureaucratic obligations.

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] 443 [Entry Date] 04/22/2011 at 04:23:52 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] 444 [Entry Date] 04/22/2011 at 04:28:43 PM [Affiliation] Self [Comments]

Output: Comment 1: No, NIH should not adopt the eight edition formulation Guide for activities involving animals.

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] 445 [Entry Date] 04/22/2011 at 04:41:48 PM [Affiliation] Self [Comments]

Output: Comment 1: MAJOR POINT: RESTRICTION IN THE USE OF EXPERIMENTAL COMPUNDS UNDER EVALUTION AS POSSIBLE THERAPEUTIC MEDICATIONS OR AS KEY RECEPTOR/CARRIER AGENTS THAT ALLOW MECHANISTIC UNDERSTANDING OF CELLS AND RODENT PHYSIOLOGY WOULD CONSIDERABLY IMPEDE FUTRE MEDICAL BENEFITS FROM ANIMAL RESEARCH

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


Input: [ID] 446 [Entry Date] 04/22/2011 at 05:19:04 PM [Affiliation] Self [Comments]

Output: Comment 1: The revised guide makes abrupt and costly changes to the care and use of laboratory animals, often without any scientific basis. Adoption of the eighth edition and implementation of plans based on that edition should be delayed while the scientific basis for changes is evaluated. Any changes determined to be justified by data should be implemented gradually to minimize the harm to already stretched budgets. Comment 2: The revised guide makes abrupt and costly changes to the care and use of laboratory animals, often without any scientific basis. Adoption of the eighth edition and implementation of plans based on that edition should be delayed while the scientific basis for changes is evaluated. Any changes determined to be justified by data should be implemented gradually to minimize the harm to already stretched budgets.

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] 447 [Entry Date] 04/22/2011 at 06:57:48 PM [Affiliation] Self [Comments]

Output: Comment 1: No. It is unclear how the eighth edition of the Guide for the Care and Use of Laboratory Animals will benefit animal welfare. There is no clear scientific justification for the proposed policy changes, which will undoubtedly increase the cost of animal research to both individuals and institutions and will increase the amount of animals required for sound basic research.

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


Input: [ID] 448 [Entry Date] 04/22/2011 at 07:49:00 PM [Affiliation] Self [Organization Name] Univ of IL [Organization City and State] Chicago IL [Comments]

Output: Comment 1: The guideline will have mankind and fail to benefits animals.

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] 449 [Entry Date] 04/22/2011 at 08:01:09 PM [Affiliation] Organization [Organization Name] University of Wisconsin-Eau Claire [Organization City and State] Eau Claire, WI [Comments]

Output: Comment 1: Do Not Adopt Comment 2: Do Not Adopt

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] 450 [Entry Date] 04/22/2011 at 10:47:20 PM [Affiliation] Self [Comments]

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

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


Input: [ID] 451 [Entry Date] 04/22/2011 at 11:43:57 PM [Affiliation] Self [Comments]

Output: Comment 1: Absolutely not. There is no scientific rationale. It is difficult to discern who is behind this proposal. Cage manufacturers? It's hard not to be cynical here. This is a terrible, terrible initiative. Implementation would greatly hurt scientific research on several levels. Comment 2: Totally superfluous.

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] 452 [Entry Date] 04/23/2011 at 12:28:29 AM [Affiliation] Self [Comments]

Output: Comment 1: There is no good substantive reason for a new guide. Just because a guide is a few years old doesn't mean it needs to be changed. Comment 2: 2012 is unreasonable, even if there were strong reasons for a new guide. Much research would be disrupted in attempting to meet this time frame. A 4-5 year time frame would allow steady, systematic changes.

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


Input: [ID] 453 [Entry Date] 04/23/2011 at 07:46:22 AM [Affiliation] Self [Comments]

Output: Comment 1: I am AGAINST adoption of the new edition of the Guide 8th edition of the "Guide for the Care and Use of Laboratory Animals"

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] 454 [Entry Date] 04/23/2011 at 10:34:32 AM [Affiliation] Self [Comments]

Output: Comment 1: NO. This new version is overly burdensome without scientific rationale. The new version 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" without any basis. Why were no scientists consulted? Compliance with these new "policy" statements may increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs). However, the scientific data justifying these expense changes is non-existent. Adherence to the 2011 Guide will require large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. The policy changes implemented by the new Guide will 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] 455 [Entry Date] 04/23/2011 at 10:52:19 AM [Affiliation] Organization [Organization Name] Temple University [Organization City and State] Philadelphia, PA [Comments]

Output: Comment 1: NO.The new guide was originally supposed to be an "update" of the 1996 Guide, however the final product is twice as long and contains a great deal of new "policy." Compliance with these new "policy" statements 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] 456 [Entry Date] 04/23/2011 at 11:11:35 AM [Affiliation] Self [Comments]

Output: Comment 1: No Comment 2: OLAW should require institutionla compliance with the new Guide no sooner than March 2015 to allow for the collection of relevant data. We are scientist, so is the ata 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] 457 [Entry Date] 04/23/2011 at 11:21:49 AM [Affiliation] Self [Comments]

Output: Comment 1: Existing regulations are more than adequate to assure humane treatment of animals. Stricter standards as proposed are unnecessary. It is inappropriate and cost ineffective to apply all the same standards to animals as a required for people.

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] 458 [Entry Date] 04/23/2011 at 11:29:45 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