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, 67745-67746 [2019-26682]

Download as PDF lotter on DSKBCFDHB2PROD with NOTICES Federal Register / Vol. 84, No. 238 / Wednesday, December 11, 2019 / Notices CFR part 2634 because these references are no longer applicable. The appendices, which contained the model Certificate of Independence and model Certificate of Compliance (items (K) and (L), respectively, on the table above), were eliminated as part of recent changes made by OGE to the Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture regulation at 5 CFR part 2634. The changes went into effect on January 1, 2019. The information previously found in Appendix B is available on www.oge.gov. Second, OGE proposes removing all references to facsimile as the best means of communication and replacing it with email. Third, with regard to the model communications (item (A) in the table above), OGE proposes to update the dates in the sample documents to make them more contemporary. Fourth, OGE proposes to add one sentence to the Privacy Act statements to better notify users of the consequences of not providing the requested information. Fifth, OGE proposes to make a few minor formatting corrections and to fix a typographical error in the Privacy Act statements. Sixth, OGE proposes to update the Privacy Act statement in accordance with recent changes made to the OGE/ GOVT–1 system of records, covering Executive Branch Personnel Public Financial Disclosure Reports and Other Name-Retrieved Ethics Program Records. The changes were effective on November 8, 2019. On September 25, 2019, OGE published a first round notice of its intent to request approval for the modified model trust certificates and trust documents under the Paperwork Reduction Act. See 84 FR 50449. OGE received no responses to that notice. Request for Comments: Agency and public comment is again invited specifically on the need for and practical utility of this information collection, the accuracy of OGE’s burden estimate, the enhancement of quality, utility, and clarity of the information collected, and the minimization of burden (including the use of information technology). Comments received in response to this notice will be summarized for, and may be included with, the OGE request for extension of OMB approval. The comments will also become a matter of public record. VerDate Sep<11>2014 16:23 Dec 10, 2019 Jkt 250001 67745 Approved: December 5, 2019. Emory Rounds, Director, Office of Government Ethics. Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species—21 CFR Part 516 [FR Doc. 2019–26605 Filed 12–10–19; 8:45 am] OMB Control Number 0910–0605— Extension The Minor Use and Minor Species (MUMS) Act (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 (e.g., 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 (e.g., 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 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 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 June 12, 2019 (84 FR 27333), FDA published a 60-day notice requesting public comment on the proposed collection of BILLING CODE 6345–03–P 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. 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. SUMMARY: Fax written comments on the collection of information by January 10, 2020. DATES: 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\11DEN1.SGM 11DEN1 67746 Federal Register / Vol. 84, No. 238 / Wednesday, December 11, 2019 / Notices information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING 1 Number of respondents 21 CFR Section 516.20; 516.26; 516.27; 516.29; 516.30; 516.36; 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, and has not changed since the last OMB approval. Dated: December 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26682 Filed 12–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–E–2617] Determination of Regulatory Review Period for Purposes of Patent Extension; VABOMERE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VABOMERE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic SUMMARY: lotter on DSKBCFDHB2PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 16:23 Dec 10, 2019 Jkt 250001 or written comments and ask for a redetermination by February 10, 2020. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 8, 2020. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 10, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://www.regulations.gov. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 • 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2018–E–2617 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; VABOMERE.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 84, Number 238 (Wednesday, December 11, 2019)]
[Notices]
[Pages 67745-67746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26682]


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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 
10, 2020.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed 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) Act (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 (e.g., 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 (e.g., 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 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 June 12, 2019 (84 FR 27333), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 67746]]

information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                     Table 1--Estimated Annual Reporting \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
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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, and has not changed since the 
last OMB approval.

    Dated: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26682 Filed 12-10-19; 8:45 am]
BILLING CODE 4164-01-P

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