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, 93941-93942 [2016-30770]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices 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No. FDA– 2014–D–2275 for ‘‘Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets 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.’’ We will review this copy, including the claimed confidential information, in our 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 https:// 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 https:// 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 VerDate Sep<11>2014 17:40 Dec 21, 2016 Jkt 241001 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 draft guidance to the Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Julie N. Barrows, Center for Food Safety and Applied Nutrition (HFS–106), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1119. 93941 II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Cosmetics/ GuidanceRegulation/default.htm or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: December 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–30781 Filed 12–21–16; 8:45 am] BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration SUPPLEMENTARY INFORMATION: [Docket No. FDA–2016–N–2474] I. Background FDA is announcing the availability of a draft guidance for industry entitled, ‘‘Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level.’’ This draft guidance provides a recommended maximum level of 10 ppm for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States. FDA has concluded that a recommended maximum level of 10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics would not pose a health risk. We consider the recommended maximum lead level to be achievable with the use of good manufacturing practices. Additionally, the recommended maximum level is consistent with the 10 ppm maximum lead level for similar products recommended by other countries. This draft guidance does not apply to topically applied products that are classified as drugs or to hair dyes that contain lead acetate as an ingredient. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on ‘‘Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level.’’ 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. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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. 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 oira_ submission@omb.eop.gov. 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. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed FOR FURTHER INFORMATION CONTACT: E:\FR\FM\22DEN1.SGM 22DEN1 93942 Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices 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; § 516.26 provides requirements for amending MUMS-drug designation; § 516.27 provides for change in sponsorship of MUMS-drug designation; § 516.29 provides for termination of MUMS-drug designation; § 516.30 contains the requirements for annual reports from sponsor(s) of MUMS-designated drugs; and § 516.36 sets forth consequences for insufficient quantities of MUMSdesignated 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 respondents 21 CFR Section 516.20; 516.26; 516.27; 516.29; 516.30; 516.36; Number of responses per respondent Total annual responses Average burden per response Total hours Content and format of MUMS request ................... Requirements for amending MUMS designation ... Change in sponsorship ........................................... Termination of MUMS designation ......................... Requirements of annual reports ............................. Insufficient quantities .............................................. 15 3 1 2 15 1 5 1 1 1 5 1 75 3 1 2 75 1 16 2 1 1 2 3 1,200 6 1 2 150 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] sradovich on DSK3GMQ082PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:40 Dec 21, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (the Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443–6593, or visit our Web site at: http://www.hrsa.gov/ vaccinecompensation/index.html. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to E:\FR\FM\22DEN1.SGM 22DEN1

Agencies

[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93941-93942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30770]


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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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.

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