Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions, 32827-32828 [2017-14998]

Download as PDF 32827 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices animal drug application for which payment is made. The form, when completed electronically, will result in the generation of a unique payment identification number used by FDA to track the payment. FDA’s Center for Veterinary Medicine and FDA’s Office of Management will use the information collected to initiate the administrative screening of new animal drug applications and supplements to determine whether the payment has been received. Description of Respondents: Respondents to this collection of information are new animal drug applicants. In the Federal Register of October 21, 2016 (81 FR 72810), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FD&C act section/ description FDA form No. 740(a)(1); Animal Drug User Fee cover sheet. FDA 3546 ........................... 1 There Dated: July 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–14997 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–N–0037] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions Food and Drug Administration, HHS. sradovich on DSK3GMQ082PROD with NOTICES ACTION: Number of responses per respondent 21 Total annual responses 1 21 Average burden per response Total hours 1 21 are no capital costs or operating and maintenance costs associated with this collection of information. The estimates in table 1 are based on our experience with new animal drug applications and supplemental animal drug applications and the average number of Animal Drug User Fee cover sheets submitted during fiscal years 2013–2015. We estimate 21 respondents will each submit a cover sheet (Form FDA 3546) for a total of 21 responses. We calculate a reporting burden of 1 hour per response, for a total of 21 hours. The burden hours are increased. The overall increase in burden hours (by 4 hours) is due to the normal variation in the number of Animal Drug User Fee cover sheets submitted to FDA. AGENCY: Number of respondents Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 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 August 17, 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 0910–0540. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7726, PRAStaff@fda.hhs.gov. 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. Animal Drug User Fees and Fee Waivers and Reductions OMB Control Number 0910–0540—Extension Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L. 108– 130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 740 of the FD&C Act (21 U.S.C 379j–12), which requires that FDA assess and collect user fees with PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 respect to new animal drug applications for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of, those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled ‘‘Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.’’ This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA’s animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA’s process for reviewing requests. FDA uses the information submitted by respondents to determine whether to grant the requested fee waiver or reduction. Respondents to this collection of information are new animal drug sponsors. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed, including application fees, product fees, establishment fees, or sponsor fees. In the Federal Register of October 17, 2016 (81 FR 71506), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. FDA estimates the burden of this collection of information as follows: E:\FR\FM\18JYN1.SGM 18JYN1 32828 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents FD&C act section/activity 740(d)(1)(A); significant barrier to innovation 55 740(d)(1)(B); fees exceed cost ..................... 740(d)(1)(C); free choice feeds .................... 8 5 740(d)(1)(D); minor use or minor species .... 69 740(d)(1)(E); small business ........................ 1 Request for reconsideration of a decision .... 1 Request for review (user fee appeal officer) 0 Total ....................................................... 1 There Dated: July 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–14998 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) 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 August 17, 2017. SUMMARY: sradovich on DSK3GMQ082PROD with NOTICES Total hours 1 time for each application. 3.75 ........................... 1 time for each application. 1 time for each application. 1 time for each application. 1 time for each application. 1 time for each application. 55 2 ................................ 110 30 5 .5 (30 minutes) .......... 2 ................................ 15 10 69 2 ................................ 138 1 2 ................................ 2 1 2 ................................ 2 0 0 ................................ 0 ................................... ........................ ................................... 277 are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA’s database system, from fiscal year (FY) 2014 to 2016 there were an estimated 177 sponsors subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the average number of submission types received by FDA in FY 2014 to 2016. The burden has not changed since the last OMB approval. AGENCY: ........................ Average burden per response Total annual responses VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 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 0910–0053. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezutto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. 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. Radioactive Drug Research Committees OMB Control Number 0910–0053— Extension Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. Section 361.1 (21 CFR 361.1) sets forth specific regulations regarding the establishment and composition of Radioactive Drug Research Committees (RDRCs) and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulation, and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each RDRC shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. Minutes shall be kept and shall include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC shall submit an annual report to FDA. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the RDRC, using Form FDA 2914, and a summary of each study conducted during the preceding year, using Form FDA 2915. Under § 361.1(d)(5), each investigator shall obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant, or on the basis of a pregnancy test be confirmed as not pregnant. Under § 361.1(d)(8), the investigator shall immediately report to the RDRC all adverse effects associated with use of the drug, and the committee shall then report to FDA all adverse reactions probably attributed to the use of the radioactive drug. Section 361.1(f) sets forth labeling requirements for radioactive drugs. E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32827-32828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug User Fee
Act Waivers and Reductions

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 August
17, 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 0910-0540.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.

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.

Animal Drug User Fees and Fee Waivers and Reductions OMB Control Number
0910-0540--Extension

Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L.
108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which
requires that FDA assess and collect user fees with respect to new
animal drug applications for certain applications, products,
establishments, and sponsors. It also requires the Agency to grant a
waiver from, or a reduction of, those fees in certain circumstances.
Thus, to implement this statutory provision of ADUFA, FDA developed a
guidance entitled ``Guidance for Industry: Animal Drug User Fees and
Fee Waivers and Reductions.'' This document provides guidance on the
types of fees FDA is authorized to collect under ADUFA, and how to
request waivers and reductions from FDA's animal drug user fees.
Further, this guidance also describes the types of fees and fee waivers
and reductions; what information FDA recommends be submitted in support
of a request for a fee waiver or reduction; how to submit such a
request; and FDA's process for reviewing requests. FDA uses the
information submitted by respondents to determine whether to grant the
requested fee waiver or reduction.
Respondents to this collection of information are new animal drug
sponsors. Requests for waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed, including
application fees, product fees, establishment fees, or sponsor fees.
In the Federal Register of October 17, 2016 (81 FR 71506), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:

[[Page 32828]]

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FD&C act section/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant 55 1 time for each 55 2.............. 110
barrier to innovation. application.
740(d)(1)(B); fees exceed 8 3.75............ 30 .5 (30 minutes) 15
cost.
740(d)(1)(C); free choice 5 1 time for each 5 2.............. 10
feeds. application.
740(d)(1)(D); minor use or 69 1 time for each 69 2.............. 138
minor species. application.
740(d)(1)(E); small business. 1 1 time for each 1 2.............. 2
application.
Request for reconsideration 1 1 time for each 1 2.............. 2
of a decision. application.
Request for review (user fee 0 1 time for each 0 0.............. 0
appeal officer). application.
----------------------------------------------------------------------------------
Total.................... .............. ................ .............. ............... 277
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Based on FDA's database system, from fiscal year (FY) 2014 to 2016
there were an estimated 177 sponsors subject to ADUFA. However, not all
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of waiver requests is based on
the average number of submission types received by FDA in FY 2014 to
2016. The burden has not changed since the last OMB approval.

Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14998 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P

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