81 FR 26236 - Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended To Diagnose, Cure, Mitigate, Treat, or Prevent Diseases; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 84 (May 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 84 (May 2, 2016)
| Page Range | 26236-26237 | |
| FR Document | 2016-10234 |
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)] [Notices] [Pages 26236-26237] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10234] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0755] Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended To Diagnose, Cure, Mitigate, Treat, or Prevent Diseases; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.'' This CPG provides guidance to FDA staff on issues related to dog and cat diets that are labeled and/or marketed as intending to diagnose, cure, mitigate, treat, or prevent diseases and to provide all or most nutrients in support of meeting the animal's total daily nutrient requirements. This CPG finalizes the draft CPG entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats,'' dated September 10, 2012. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-D-0755 for ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets [[Page 26237]] Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: William J. Burkholder, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5900; email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 10, 2012 (77 FR 55480), FDA published the notice of availability for a draft CPG entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats'' giving interested persons until November 9, 2012, to comment on the draft CPG. FDA received several comments on the draft CPG and those comments were considered as the CPG was finalized. FDA revised the title of the final CPG. The final CPG is entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.'' In addition to revising the title, editorial changes were made to improve clarity. The CPG announced in this notice finalizes the draft CPG dated September 10, 2012. II. Significance of Guidance This level 1 CPG is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on labeling and marketing of dog and cat food diets intended to diagnose, cure, mitigate, treat, or prevent diseases. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. In the Federal Register of September 10, 2012 (77 FR 55480), FDA published a notice announcing the availability of the draft CPG. This document contained a Paperwork Reduction Act burden analysis and requested comments on a proposed collection of information (77 FR 55480 at 55481). We have concluded that our guidance to FDA staff with respect to factors to consider when determining whether to take regulatory action against an article of dog or cat food does not impose collection of information burdens on the public. In addition, to the extent that we obtain information during an enforcement action, this collection is exempt from OMB review under 44 U.S.C. 3518(c)(1)(B) and 5 CFR 1320.4(a)(2) as collection of information obtained during the conduct of a civil action to which the United States or any official or agency thereof is a party, or during the conduct of an administrative action, investigation, or audit involving an agency against specific individuals or entities. The regulations in 5 CFR 1320(c) provide that the exception in 5 CFR 1320.4(a)(2) applies during the entire course of the investigation, audit, or action, but only after a case file or equivalent is opened with respect to a particular party. Such a case file would be opened, for example, as part of the decision to detain a drug or an article of food. IV. Electronic Access Persons with access to the Internet may obtain the CPG at either http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm under ``Compliance Policy Guides'' or http://www.regulations.gov. Dated: April 25, 2016. Katherine Bent, Assistant Commissioner for Compliance Policy. [FR Doc. 2016-10234 Filed 4-29-16; 8:45 am] BILLING CODE 4164-01-P
![26236 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
Total Annual Responses: 12,810; Total conduct their own analysis, to the Dogs and Cats,’’ dated September 10,
Annual Hours: 3,618,703. (For policy extent they propose to do such tasks. 2012.
questions regarding this collection The states have been funded under the DATES: Submit either electronic or
contact Samone Angel at 410–786– demonstration grant to conduct the written comments on Agency guidances
1123.) round 2 data collection and analysis. at any time.
2. Type of Information Collection These states will submit reports to CMS
Request: Reinstatement with change of a ADDRESSES: You may submit comments
describing their experience in the
previously approved collection; Title of Round 2 data collection, including the as follows:
Information Collection: Testing items they collected, how they planned Electronic Submissions
Experience and Functional Tools: to use the data, and the types of
Functional Assessment Standardized Submit electronic comments in the
challenges and successes they
Items (FASI) Based on the CARE Tool; following way:
encountered in doing so. The reports
Use: In 2012, CMS funded a project • Federal eRulemaking Portal: http://
may be used by CMS in their evaluation
entitled, Technical Assistance to States www.regulations.gov. Follow the
of the TEFT grants. Form Number:
for Testing Experience and Functional instructions for submitting comments.
CMS–10243 (OMB control number:
Tools (TEFT) Grants. One component of 0938–1037); Frequency: On occasion; Comments submitted electronically,
this demonstration is to amend and test Affected Public: Individuals and including attachments, to http://
the reliability of a setting-agnostic, households; Number of Respondents: www.regulations.gov will be posted to
interoperable set of data elements, 5,650; Total Annual Responses: 5,650; the docket unchanged. Because your
called ‘‘items,’’ that can support Total Annual Hours: 2,825. (For policy comment will be made public, you are
standardized assessment of individuals questions regarding this collection solely responsible for ensuring that your
across the continuum of care. Items that contact Allison Weaver at 410–786– comment does not include any
were created for use in post-acute care 4924.) confidential information that you or a
settings using the Continuity third party may not wish to be posted,
Dated: April 27, 2016. such as medical information, your or
Assessment Record and Evaluation
William N. Parham, III, anyone else’s Social Security number, or
(CARE) tool have been adopted,
Director, Paperwork Reduction Staff, Office confidential business information, such
modified, or supplemented for use in of Strategic Operations and Regulatory
community-based long-term services as a manufacturing process. Please note
Affairs. that if you include your name, contact
and supports (CB–LTSS) programs. This
[FR Doc. 2016–10232 Filed 4–29–16; 8:45 am] information, or other information that
project will test the reliability and
validity of the function-related BILLING CODE 4120–01–P identifies you in the body of your
assessment items, now referred to as comments, that information will be
Functional Assessment Standardized posted on http://www.regulations.gov.
DEPARTMENT OF HEALTH AND • If you want to submit a comment
Items (FASI), when applied in HUMAN SERVICES
community settings, and in various with confidential information that you
populations: Elders (65 years and older); Food and Drug Administration do not wish to be made available to the
younger adults (18–64) with physical public, submit the comment as a
disabilities; and adults of any age with [Docket No. FDA–2012–D–0755] written/paper submission and in the
intellectual or developmental manner detailed (see ‘‘Written/Paper
Compliance Policy Guide Sec. 690.150 Submissions’’ and ‘‘Instructions’’).
disabilities, with severe mental illness, Labeling and Marketing of Dog and Cat
or with traumatic brain injury. Food Diets Intended To Diagnose, Written/Paper Submissions
Individual-level data will be collected
Cure, Mitigate, Treat, or Prevent Submit written/paper submissions as
two times using the TEFT FASI Item
Diseases; Availability follows:
Set. The first data collection effort will
collect data that can be analyzed to AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
evaluate the reliability and validity of HHS. written/paper submissions): Division of
the FASI items when used with the five ACTION: Notice. Dockets Management (HFA–305), Food
waiver populations. Assessors will and Drug Administration, 5630 Fishers
conduct functional assessments in client SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
homes using the TEFT FASI Item Set. Administration (FDA) is announcing the • For written/paper comments
Changes may be recommended to availability of a compliance policy submitted to the Division of Dockets
individual TEFT FASI items, to be made guide (CPG) entitled ‘‘Compliance Management, FDA will post your
prior to releasing the TEFT FASI items Policy Guide Sec. 690.150 Labeling comment, as well as any attachments,
for use by the states. The FASI Field and Marketing of Dog and Cat Food except for information submitted,
Test Report will be released to the Diets Intended to Diagnose, Cure, marked and identified, as confidential,
public. Mitigate, Treat, or Prevent Diseases.’’ if submitted as detailed in
The second data collection will be This CPG provides guidance to FDA ‘‘Instructions.’’
conducted by the states to demonstrate staff on issues related to dog and cat Instructions: All submissions received
their use of the FASI data elements. The diets that are labeled and/or marketed as must include the Docket No. FDA–
assessment data could be used by the intending to diagnose, cure, mitigate, 2012–D–0755 for ‘‘Compliance Policy
states for multiple purposes. They may treat, or prevent diseases and to provide Guide Sec. 690.150 Labeling and
use the standardized items to determine all or most nutrients in support of Marketing of Dog and Cat Food Diets
srobinson on DSK5SPTVN1PROD with NOTICES
individual eligibility for state programs, meeting the animal’s total daily nutrient Intended to Diagnose, Cure, Mitigate,
or to help determine levels of care requirements. This CPG finalizes the Treat, or Prevent Diseases.’’ Received
within which people can receive draft CPG entitled ‘‘Compliance Policy comments will be placed in the docket
services, or other purposes. In the Guide Sec. 690.150 Labeling and and, except for those submitted as
second round of data collection, states Marketing of Nutritional Products ‘‘Confidential Submissions,’’ publicly
will demonstrate their proposed uses, Intended for Use to Diagnose, Cure, viewable at http://www.regulations.gov
manage their FASI data collection and Mitigate, Treat, or Prevent Disease in or at the Division of Dockets
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![Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices 26237
Management between 9 a.m. and 4 p.m., 5900; email: William.Burkholder@ determining whether to take regulatory
Monday through Friday. fda.hhs.gov. action against an article of dog or cat
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: food does not impose collection of
submit a comment with confidential information burdens on the public. In
information that you do not wish to be I. Background addition, to the extent that we obtain
made publicly available, submit your In the Federal Register of September information during an enforcement
comments only as a written/paper 10, 2012 (77 FR 55480), FDA published action, this collection is exempt from
submission. You should submit two the notice of availability for a draft CPG OMB review under 44 U.S.C.
copies total. One copy will include the entitled ‘‘Compliance Policy Guide Sec. 3518(c)(1)(B) and 5 CFR 1320.4(a)(2) as
information you claim to be confidential 690.150 Labeling and Marketing of collection of information obtained
with a heading or cover note that states Nutritional Products Intended for Use to during the conduct of a civil action to
‘‘THIS DOCUMENT CONTAINS Diagnose, Cure, Mitigate, Treat, or which the United States or any official
CONFIDENTIAL INFORMATION.’’ The Prevent Disease in Dogs and Cats’’ or agency thereof is a party, or during
Agency will review this copy, including giving interested persons until the conduct of an administrative action,
the claimed confidential information, in November 9, 2012, to comment on the investigation, or audit involving an
its consideration of comments. The draft CPG. FDA received several agency against specific individuals or
second copy, which will have the comments on the draft CPG and those entities. The regulations in 5 CFR
claimed confidential information comments were considered as the CPG 1320(c) provide that the exception in 5
redacted/blacked out, will be available was finalized. CFR 1320.4(a)(2) applies during the
for public viewing and posted on FDA revised the title of the final CPG. entire course of the investigation, audit,
http://www.regulations.gov. Submit The final CPG is entitled ‘‘Compliance or action, but only after a case file or
both copies to the Division of Dockets Policy Guide Sec. 690.150 Labeling and equivalent is opened with respect to a
Management. If you do not wish your Marketing of Dog and Cat Food Diets particular party. Such a case file would
name and contact information to be Intended to Diagnose, Cure, Mitigate, be opened, for example, as part of the
made publicly available, you can Treat, or Prevent Diseases.’’ In addition decision to detain a drug or an article of
provide this information on the cover to revising the title, editorial changes food.
sheet and not in the body of your were made to improve clarity.
The CPG announced in this notice IV. Electronic Access
comments and you must identify this
finalizes the draft CPG dated September Persons with access to the Internet
information as ‘‘confidential.’’ Any
10, 2012. may obtain the CPG at either http://
information marked as ‘‘confidential’’
will not be disclosed except in II. Significance of Guidance www.fda.gov/ICECI/
accordance with 21 CFR 10.20 and other ComplianceManuals/
This level 1 CPG is being issued CompliancePolicyGuidanceManual/
applicable disclosure law. For more consistent with FDA’s good guidance
information about FDA’s posting of default.htm under ‘‘Compliance Policy
practices regulation (21 CFR 10.115). Guides’’ or http://www.regulations.gov.
comments to public dockets, see 80 FR The guidance represents the current
56469, September 18, 2015, or access thinking of FDA on labeling and Dated: April 25, 2016.
the information at: http://www.fda.gov/ marketing of dog and cat food diets Katherine Bent,
regulatoryinformation/dockets/ intended to diagnose, cure, mitigate, Assistant Commissioner for Compliance
default.htm. treat, or prevent diseases. It does not Policy.
Docket: For access to the docket to establish any rights for any person and [FR Doc. 2016–10234 Filed 4–29–16; 8:45 am]
read background documents or the is not binding on FDA or the public. BILLING CODE 4164–01–P
electronic and written/paper comments You can use an alternative approach if
received, go to http:// it satisfies the requirements of the
www.regulations.gov and insert the applicable statutes and regulations. DEPARTMENT OF HEALTH AND
docket number, found in brackets in the HUMAN SERVICES
III. Paperwork Reduction Act of 1995
heading of this document, into the
‘‘Search’’ box and follow the prompts Under the Paperwork Reduction Act Office of the Assistant Secretary for
and/or go to the Division of Dockets of 1995 (the PRA) (44 U.S.C. 3501– Health
Management, 5630 Fishers Lane, Rm. 3520), Federal Agencies must obtain
approval from the Office of Management [Document Identifier: HHS–OS–0990–New–
1061, Rockville, MD 20852.
and Budget (OMB) for each collection of 60D]
Submit written requests for single
copies of the guidance to the Policy and information they conduct or sponsor.
Agency Information Collection
Regulations Staff (HFV–6), Center for ‘‘Collection of information’’ is defined
Activities; Proposed Collection; Public
Veterinary Medicine, Food and Drug in 44 U.S.C. 3502(3) and 5 CFR 1320.3
Comment Request
Administration, 7519 Standish Pl., and includes Agency requests or
Rockville, MD 20855. Send one self- requirements that members of the public ACTION: Notice.
addressed adhesive label to assist that submit reports, keep records, or provide
office in processing your requests. See information to a third party. In the SUMMARY: In compliance with section
the SUPPLEMENTARY INFORMATION section Federal Register of September 10, 2012 3506(c)(2)(A) of the Paperwork
for electronic access to the guidance (77 FR 55480), FDA published a notice Reduction Act of 1995, the Office of the
announcing the availability of the draft Assistant Secretary for Health (OASH),
srobinson on DSK5SPTVN1PROD with NOTICES
document.
CPG. This document contained a Department of Health and Human
FOR FURTHER INFORMATION CONTACT: Paperwork Reduction Act burden Services, announces plans to submit a
William J. Burkholder, Center for analysis and requested comments on a new Information Collection Request
Veterinary Medicine, Division of proposed collection of information (77 (ICR), described below, to the Office of
Animal Feeds (HFV–220), Food and FR 55480 at 55481). We have concluded Management and Budget (OMB). Prior
Drug Administration, 7519 Standish that our guidance to FDA staff with to submitting the ICR to OMB, OASH
Place, Rockville, MD 20855, 240–402– respect to factors to consider when seeks comments from the public
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Document Created: 2016-04-30 13:34:36
Document Modified: 2016-04-30 13:34:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | William J. Burkholder, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5900; email: [email protected] | |
| FR Citation | 81 FR 26236 |
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