Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 32828-32829 [2017-15000]

Download as PDF 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 32829 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)). Types of research studies not permitted under this regulation are also specified, and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an investigational new drug application under 21 CFR part 312, and the associated information collections are covered in OMB control number 0910– 0014. The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson(s) of each individual RDRC, investigators, and participants in the studies. The burden estimates are based on FDA’s experience with these reporting and recordkeeping requirements and the number of submissions received by FDA under the regulations over the past 3 years. In the Federal Register of April 25, 2017 (82 FR 19052), we published a 60day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We therefore estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section/Form FDA Number of responses per respondent Total annual responses Average burden per response Total hours 361.1(c)(3) (Reports) and (c)(4) (Approval); Form FDA 2914 (Membership Summary) .......................................... 361.1(c)(3) (Reports); Form FDA 2915 (Study Summary) .. 361.1(c)(8) (Adverse Events) ............................................... 69 35 10 1 14 1 69 490 10 1 3.5 * 0.5 69 1,715 5 Total .............................................................................. ........................ ........................ 569 ........................ 1,789 1 There are no capital or operating and maintenance costs associated with the information collection. * 30 minutes. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 361.1(c)(2) ............................................................................ 361.1(d)(5) ........................................................................... 69 35 4 14 276 490 10 * 0.75 2,760 368 Total .............................................................................. ........................ ........................ 766 ........................ 3,128 1 There are no capital or operating and maintenance costs associated with the information collection. * 45 minutes. Dated: July 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–15000 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3GMQ082PROD with NOTICES [Docket No. FDA–2017–N–2428] Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA’s existing reporting and recordkeeping requirements for animal drug adverse events and product/manufacturing defects. 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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 2017. 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. SUMMARY: ADDRESSES: Submit either electronic or written comments on the collection of information by September 18, 2017. 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 DATES: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32828-32829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15000]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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.

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 0910-0053.
Also include the FDA docket number found in brackets in the heading of
this document.

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 an FDA-
approved RDRC (Sec. 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 Sec. 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 Sec. 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 Sec. 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.

[[Page 32829]]

These requirements are not in the reporting burden estimate because
they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
Types of research studies not permitted under this regulation are
also specified, and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application under 21 CFR part
312, and the associated information collections are covered in OMB
control number 0910-0014.
The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson(s) of
each individual RDRC, investigators, and participants in the studies.
The burden estimates are based on FDA's experience with these reporting
and recordkeeping requirements and the number of submissions received
by FDA under the regulations over the past 3 years.
In the Federal Register of April 25, 2017 (82 FR 19052), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We therefore estimate the burden of this collection of information
as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/Form FDA Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
361.1(c)(3) (Reports) and (c)(4) 69 1 69 1 69
(Approval); Form FDA 2914
(Membership Summary)...........
361.1(c)(3) (Reports); Form FDA 35 14 490 3.5 1,715
2915 (Study Summary)...........
361.1(c)(8) (Adverse Events).... 10 1 10 * 0.5 5
-------------------------------------------------------------------------------
Total....................... .............. .............. 569 .............. 1,789
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
* 30 minutes.

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)..................... 69 4 276 10 2,760
361.1(d)(5)..................... 35 14 490 * 0.75 368
-------------------------------------------------------------------------------
Total....................... .............. .............. 766 .............. 3,128
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
* 45 minutes.

Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15000 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P

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