81 FR 93941 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 246 (December 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 246 (December 22, 2016)
| Page Range | 93941-93942 | |
| FR Document | 2016-30770 |
[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)] [Notices] [Pages 93941-93942] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30770] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2474] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 23, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0605. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed [[Page 93942]] collection of information to OMB for review and clearance. Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species; 21 CFR Part 516 OMB Control Number 0910-0605--Extension The Minor Use and Minor Species (MUMS) Animal Health Act of 2004 (Pub. L. 108-282) amended the Federal Food, Drug, and Cosmetic Act to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. This legislation provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing limited-demand animal drugs. These incentives are only available to sponsors whose drugs are ``MUMS-designated'' by FDA. Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of animals either because they occur infrequently or in limited geographic areas. Minor species are all animals other than the major species; for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include animals such as sheep, goats, catfish, and honeybees. Participation in the MUMS program is completely optional for drug sponsors so the associated reporting only applies to those sponsors who request and are subsequently granted ``MUMS designation.'' Our regulations in 21 CFR part 516 specify the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees. Section 516.20 (21 CFR 516.20) provides requirements on the content and format of a request for MUMS-drug designation; Sec. 516.26 provides requirements for amending MUMS-drug designation; Sec. 516.27 provides for change in sponsorship of MUMS-drug designation; Sec. 516.29 provides for termination of MUMS-drug designation; Sec. 516.30 contains the requirements for annual reports from sponsor(s) of MUMS-designated drugs; and Sec. 516.36 sets forth consequences for insufficient quantities of MUMS-designated drugs. Description of Respondents: The respondents to this information collection are pharmaceutical companies that sponsor new animal drugs. In the Federal Register of August 22, 2016 (81 FR 56658), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR Section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 516.20; Content and format of 15 5 75 16 1,200 MUMS request................... 516.26; Requirements for 3 1 3 2 6 amending MUMS designation...... 516.27; Change in sponsorship... 1 1 1 1 1 516.29; Termination of MUMS 2 1 2 1 2 designation.................... 516.30; Requirements of annual 15 5 75 2 150 reports........................ 516.36; Insufficient quantities. 1 1 1 3 3 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,362 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate for this reporting requirement was derived in our Office of Minor Use and Minor Species Animal Drug Development by extrapolating the investigational new animal drug/new animal drug application reporting requirements for similar actions by this same segment of the regulated industry and from previous interactions with the minor use/minor species community. Dated: December 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30770 Filed 12-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices 93941
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets II. Electronic Access
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Persons with access to the Internet
• For written/paper comments 1061, Rockville, MD 20852. may obtain the draft guidance at either
submitted to the Division of Dockets
Submit written requests for single http://www.fda.gov/Cosmetics/
Management, FDA will post your
copies of the draft guidance to the Office GuidanceRegulation/default.htm or
comment, as well as any attachments,
of Cosmetics and Colors, Center for https://www.regulations.gov. Use the
except for information submitted,
Food Safety and Applied Nutrition, FDA Web site listed in the previous
marked and identified, as confidential,
5001 Campus Dr., College Park, MD sentence to find the most current
if submitted as detailed in
20740. Send two self-addressed version of the guidance.
‘‘Instructions.’’
Instructions: All submissions received adhesive labels to assist that office in Dated: December 16, 2016.
must include the Docket No. FDA– processing your requests. See the Leslie Kux,
2014–D–2275 for ‘‘Lead in Cosmetic Lip SUPPLEMENTARY INFORMATION section for
Associate Commissioner for Policy.
Products and Externally Applied electronic access to the draft guidance
[FR Doc. 2016–30781 Filed 12–21–16; 8:45 am]
Cosmetics: Recommended Maximum document.
BILLING CODE 4164–01–P
Level; Draft Guidance for Industry;
Availability.’’ Received comments will FOR FURTHER INFORMATION CONTACT: Julie
be placed in the docket and, except for N. Barrows, Center for Food Safety and
Applied Nutrition (HFS–106), Food and DEPARTMENT OF HEALTH AND
those submitted as ‘‘Confidential HUMAN SERVICES
Submissions,’’ publicly viewable at Drug Administration, 5001 Campus Dr.,
https://www.regulations.gov or at the College Park, MD 20740, 240–402–1119. Food and Drug Administration
Division of Dockets Management SUPPLEMENTARY INFORMATION:
between 9 a.m. and 4 p.m., Monday [Docket No. FDA–2016–N–2474]
through Friday. I. Background
• Confidential Submissions—To Agency Information Collection
submit a comment with confidential FDA is announcing the availability of
Activities; Submission for Office of
information that you do not wish to be a draft guidance for industry entitled,
Management and Budget Review;
made publicly available, submit your ‘‘Lead in Cosmetic Lip Products and Comment Request; Reporting
comments only as a written/paper Externally Applied Cosmetics: Associated With Designated New
submission. You should submit two Recommended Maximum Level.’’ This Animal Drugs for Minor Use and Minor
copies total. One copy will include the draft guidance provides a recommended Species
information you claim to be confidential maximum level of 10 ppm for lead as an
with a heading or cover note that states impurity in cosmetic lip products (such AGENCY: Food and Drug Administration,
‘‘THIS DOCUMENT CONTAINS as lipsticks, lip glosses, and lip liners) HHS.
CONFIDENTIAL INFORMATION.’’ We and externally applied cosmetics (such ACTION: Notice.
will review this copy, including the as eye shadows, blushes, shampoos, and
claimed confidential information, in our body lotions) marketed in the United SUMMARY: The Food and Drug
consideration of comments. The second States. FDA has concluded that a Administration (FDA) is announcing
copy, which will have the claimed recommended maximum level of 10 that a proposed collection of
confidential information redacted/ ppm for lead as an impurity in cosmetic information has been submitted to the
blacked out, will be available for public lip products and externally applied Office of Management and Budget
viewing and posted on https:// cosmetics would not pose a health risk. (OMB) for review and clearance under
www.regulations.gov. Submit both We consider the recommended the Paperwork Reduction Act of 1995.
copies to the Division of Dockets maximum lead level to be achievable DATES: Fax written comments on the
Management. If you do not wish your with the use of good manufacturing collection of information by January 23,
name and contact information to be practices. Additionally, the 2017.
made publicly available, you can recommended maximum level is ADDRESSES: To ensure that comments on
provide this information on the cover consistent with the 10 ppm maximum the information collection are received,
sheet and not in the body of your lead level for similar products OMB recommends that written
comments and you must identify this recommended by other countries. This comments be faxed to the Office of
information as ‘‘confidential.’’ Any draft guidance does not apply to Information and Regulatory Affairs,
information marked as ‘‘confidential’’ topically applied products that are OMB, Attn: FDA Desk Officer, FAX:
will not be disclosed except in classified as drugs or to hair dyes that 202–395–7285, or emailed to oira_
accordance with 21 CFR 10.20 and other submission@omb.eop.gov. All
contain lead acetate as an ingredient.
applicable disclosure law. For more comments should be identified with the
information about FDA’s posting of This draft guidance is being issued
OMB control number 0910–0605. Also
comments to public dockets, see 80 FR consistent with FDA’s good guidance
include the FDA docket number found
56469, September 18, 2015, or access practices regulation (21 CFR 10.115).
in brackets in the heading of this
the information at: http://www.fda.gov/ The draft guidance, when finalized, will
document.
regulatoryinformation/dockets/ represent FDA’s current thinking on
default.htm. ‘‘Lead in Cosmetic Lip Products and FOR FURTHER INFORMATION CONTACT: FDA
Docket: For access to the docket to Externally Applied Cosmetics: PRA Staff, Office of Operations, Food
sradovich on DSK3GMQ082PROD with NOTICES
read background documents or the Recommended Maximum Level.’’ It and Drug Administration, Three White
electronic and written/paper comments does not establish any rights for any Flint North, 10A63, 11601 Landsdown
received, go to https:// person and is not binding on FDA or the St., North Bethesda, MD 20852,
www.regulations.gov and insert the public. You can use an alternative PRAStaff@fda.hhs.gov.
docket number, found in brackets in the approach if it satisfies the requirements SUPPLEMENTARY INFORMATION: In
heading of this document, into the of the applicable statutes and compliance with 44 U.S.C. 3507, FDA
‘‘Search’’ box and follow the prompts regulations. has submitted the following proposed
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![93942 Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
collection of information to OMB for (cattle, horses, swine, chickens, turkeys, MUMS-drug designation; § 516.26
review and clearance. dogs, and cats) that are needed for provides requirements for amending
diseases that occur in only a small MUMS-drug designation; § 516.27
Reporting Associated With Designated
number of animals either because they provides for change in sponsorship of
New Animal Drugs for Minor Use and
occur infrequently or in limited MUMS-drug designation; § 516.29
Minor Species; 21 CFR Part 516 OMB
Control Number 0910–0605—Extension geographic areas. Minor species are all provides for termination of MUMS-drug
animals other than the major species; for designation; § 516.30 contains the
The Minor Use and Minor Species example, zoo animals, ornamental fish, requirements for annual reports from
(MUMS) Animal Health Act of 2004 parrots, ferrets, and guinea pigs. Some sponsor(s) of MUMS-designated drugs;
(Pub. L. 108–282) amended the Federal animals of agricultural importance are and § 516.36 sets forth consequences for
Food, Drug, and Cosmetic Act to also minor species. These include insufficient quantities of MUMS-
authorize FDA to establish new designated drugs.
animals such as sheep, goats, catfish,
regulatory procedures intended to make
and honeybees. Participation in the Description of Respondents: The
more medications legally available to
MUMS program is completely optional respondents to this information
veterinarians and animal owners for the
for drug sponsors so the associated collection are pharmaceutical
treatment of minor animal species as
reporting only applies to those sponsors companies that sponsor new animal
well as uncommon diseases in major
who request and are subsequently drugs.
animal species. This legislation
provides incentives designed to help granted ‘‘MUMS designation.’’ In the Federal Register of August 22,
pharmaceutical companies overcome Our regulations in 21 CFR part 516 2016 (81 FR 56658), FDA published a
the financial burdens they face in specify the criteria and procedures for 60-day notice requesting public
providing limited-demand animal requesting MUMS designation as well as comment on the proposed collection of
drugs. These incentives are only the annual reporting requirements for information. No comments were
available to sponsors whose drugs are MUMS designees. Section 516.20 (21 received.
‘‘MUMS-designated’’ by FDA. Minor use CFR 516.20) provides requirements on FDA estimates the burden of this
drugs are drugs for use in major species the content and format of a request for collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR Section burden per Total hours
respondents per responses response
respondent
516.20; Content and format of MUMS request ................... 15 5 75 16 1,200
516.26; Requirements for amending MUMS designation ... 3 1 3 2 6
516.27; Change in sponsorship ........................................... 1 1 1 1 1
516.29; Termination of MUMS designation ......................... 2 1 2 1 2
516.30; Requirements of annual reports ............................. 15 5 75 2 150
516.36; Insufficient quantities .............................................. 1 1 1 3 3
Total .............................................................................. ........................ ........................ ........................ ........................ 1,362
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this reporting DEPARTMENT OF HEALTH AND with responsibility for considering and
requirement was derived in our Office HUMAN SERVICES acting upon the petitions.
of Minor Use and Minor Species Animal FOR FURTHER INFORMATION CONTACT: For
Drug Development by extrapolating the Health Resources and Services information about requirements for
investigational new animal drug/new Administration filing petitions, and the Program in
animal drug application reporting general, contact the Clerk, United States
National Vaccine Injury Compensation Court of Federal Claims, 717 Madison
requirements for similar actions by this
Program; List of Petitions Received Place NW., Washington, DC 20005,
same segment of the regulated industry
and from previous interactions with the AGENCY: Health Resources and Services (202) 357–6400. For information on
minor use/minor species community. Administration (HRSA), Department of HRSA’s role in the Program, contact the
Health and Human Services (HHS). Director, National Vaccine Injury
Dated: December 16, 2016. Compensation Program, 5600 Fishers
ACTION: Notice.
Leslie Kux, Lane, Room 08N146B, Rockville, MD
Associate Commissioner for Policy. SUMMARY: HRSA is publishing this 20857; (301) 443–6593, or visit our Web
[FR Doc. 2016–30770 Filed 12–21–16; 8:45 am] notice of petitions received under the site at: http://www.hrsa.gov/
BILLING CODE 4164–01–P National Vaccine Injury Compensation vaccinecompensation/index.html.
Program (the Program), as required by SUPPLEMENTARY INFORMATION: The
Section 2112(b)(2) of the Public Health Program provides a system of no-fault
sradovich on DSK3GMQ082PROD with NOTICES
Service (PHS) Act, as amended. While compensation for certain individuals
the Secretary of HHS (the Secretary) is who have been injured by specified
named as the respondent in all childhood vaccines. Subtitle 2 of Title
proceedings brought by the filing of XXI of the PHS Act, 42 U.S.C. 300aa–
petitions for compensation under the 10 et seq., provides that those seeking
Program, the United States Court of compensation are to file a petition with
Federal Claims is charged by statute the U.S. Court of Federal Claims and to
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Document Created: 2016-12-21 23:52:16
Document Modified: 2016-12-21 23:52:16
| 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 | Fax written comments on the collection of information by January 23, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 93941 |
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