82 FR 32828 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32828-32829 | |
| FR Document | 2017-15000 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32828-32829] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15000] ----------------------------------------------------------------------- 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 [email protected]. 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, [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. 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
![32828 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FD&C act section/activity responses per burden per Total hours
respondents responses
respondent response
740(d)(1)(A); significant barrier to innovation 55 1 time for each appli- 55 2 ................................ 110
cation.
740(d)(1)(B); fees exceed cost ..................... 8 3.75 ........................... 30 .5 (30 minutes) .......... 15
740(d)(1)(C); free choice feeds .................... 5 1 time for each appli- 5 2 ................................ 10
cation.
740(d)(1)(D); minor use or minor species .... 69 1 time for each appli- 69 2 ................................ 138
cation.
740(d)(1)(E); small business ........................ 1 1 time for each appli- 1 2 ................................ 2
cation.
Request for reconsideration of a decision .... 1 1 time for each appli- 1 2 ................................ 2
cation.
Request for review (user fee appeal officer) 0 1 time for each appli- 0 0 ................................ 0
cation.
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 ADDRESSES: To ensure that comments on an FDA-approved RDRC (§ 361.1(d)(7)).
fiscal year (FY) 2014 to 2016 there were the information collection are received, The type of research that may be
an estimated 177 sponsors subject to OMB recommends that written undertaken with a radiopharmaceutical
ADUFA. However, not all sponsors will comments be faxed to the Office of drug must be intended to obtain basic
have any submissions in a given year Information and Regulatory Affairs, information and not to carry out a
and some may have multiple OMB, Attn: FDA Desk Officer, FAX: clinical trial for safety or efficacy. The
submissions. The total number of 202–395–7285, or emailed to oira_ types of basic research permitted are
waiver requests is based on the average submission@omb.eop.gov. All specified in the regulation, and include
number of submission types received by comments should be identified with the studies of metabolism, human
FDA in FY 2014 to 2016. The burden OMB control number 0910–0053. Also physiology, pathophysiology, or
has not changed since the last OMB include the FDA docket number found biochemistry.
approval. in brackets in the heading of this Section 361.1(c)(2) requires that each
Dated: July 12, 2017. document. RDRC shall select a chairman, who shall
Anna K. Abram, FOR FURTHER INFORMATION CONTACT:
sign all applications, minutes, and
Jonnalynn Capezutto, Office of reports of the committee. Each
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. Operations, Food and Drug committee shall meet at least once each
Administration, Three White Flint quarter in which research activity has
[FR Doc. 2017–14998 Filed 7–17–17; 8:45 am]
North, 10A63, 11601 Landsdown St., been authorized or conducted. Minutes
BILLING CODE 4164–01–P
North Bethesda, MD 20852, 301–796– shall be kept and shall include the
3794, PRAStaff@fda.hhs.gov. numerical results of votes on protocols
DEPARTMENT OF HEALTH AND involving use in human subjects. Under
SUPPLEMENTARY INFORMATION: In § 361.1(c)(3), each RDRC shall submit an
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA annual report to FDA. The annual report
has submitted the following proposed shall include the names and
Food and Drug Administration collection of information to OMB for qualifications of the members of, and of
[Docket No. FDA–2010–N–0583] review and clearance. any consultants used by, the RDRC,
Agency Information Collection Radioactive Drug Research Committees using Form FDA 2914, and a summary
Activities; Submission for Office of of each study conducted during the
OMB Control Number 0910–0053— preceding year, using Form FDA 2915.
Management and Budget Review; Extension
Comment Request; Radioactive Drug Under § 361.1(d)(5), each investigator
Research Committees Under sections 201, 505, and 701 of shall obtain the proper consent required
the Federal Food, Drug, and Cosmetic under the regulations. Each female
AGENCY: Food and Drug Administration, Act (21 U.S.C. 321, 355, and 371), FDA research subject of childbearing
HHS. has the authority to issue regulations potential must state in writing that she
ACTION: Notice. governing the use of radioactive drugs is not pregnant, or on the basis of a
for basic scientific research. Section pregnancy test be confirmed as not
SUMMARY: The Food and Drug 361.1 (21 CFR 361.1) sets forth specific pregnant.
Administration (FDA or we) is regulations regarding the establishment Under § 361.1(d)(8), the investigator
announcing that a proposed collection and composition of Radioactive Drug shall immediately report to the RDRC all
sradovich on DSK3GMQ082PROD with NOTICES
of information has been submitted to the Research Committees (RDRCs) and their adverse effects associated with use of
Office of Management and Budget role in approving and monitoring basic the drug, and the committee shall then
(OMB) for review and clearance under research studies utilizing report to FDA all adverse reactions
the Paperwork Reduction Act of 1995. radiopharmaceuticals. No basic research probably attributed to the use of the
DATES: Fax written comments on the study involving any administration of a radioactive drug.
collection of information by August 17, radioactive drug to research subjects is Section 361.1(f) sets forth labeling
2017. permitted without the authorization of requirements for radioactive drugs.
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![Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32829
These requirements are not in the under 21 CFR part 312, and the studies. The burden estimates are based
reporting burden estimate because they associated information collections are on FDA’s experience with these
are information supplied by the Federal covered in OMB control number 0910– reporting and recordkeeping
Government to the recipient for the 0014. requirements and the number of
purposes of disclosure to the public (5 The primary purpose of this submissions received by FDA under the
CFR 1320.3(c)(2)). collection of information is to determine regulations over the past 3 years.
Types of research studies not whether the research studies are being
permitted under this regulation are also conducted in accordance with required In the Federal Register of April 25,
specified, and include those intended regulations and that human subject 2017 (82 FR 19052), we published a 60-
for immediate therapeutic, diagnostic, safety is assured. If these studies were day notice requesting public comment
or similar purposes or to determine the not reviewed, human subjects could be on the proposed extension of this
safety or effectiveness of the drug in subjected to inappropriate radiation or collection of information. No comments
humans for such purposes (i.e., to carry pharmacologic risks. Respondents to were received.
out a clinical trial for safety or efficacy). this information collection are the We therefore estimate the burden of
These studies require filing of an chairperson(s) of each individual RDRC, this collection of information as follows:
investigational new drug application investigators, and participants in the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section/Form FDA responses per burden per Total hours
respondents responses
respondent response
361.1(c)(3) (Reports) and (c)(4) (Approval); Form FDA
2914 (Membership Summary) .......................................... 69 1 69 1 69
361.1(c)(3) (Reports); Form FDA 2915 (Study Summary) .. 35 14 490 3.5 1,715
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
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper 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. SUMMARY: The Food and Drug ADDRESSES: You may submit comments
Anna K. Abram, Administration (FDA or Agency) is as follows. Please note that late,
Deputy Commissioner for Policy, Planning, announcing an opportunity for public untimely filed comments will not be
Legislation, and Analysis. comment on the proposed collection of considered. Electronic comments must
[FR Doc. 2017–15000 Filed 7–17–17; 8:45 am] certain information by the Agency. be submitted on or before September 18,
BILLING CODE 4164–01–P Under the Paperwork Reduction Act of 2017. The https://www.regulations.gov
1995 (PRA), Federal Agencies are electronic filing system will accept
required to publish notice in the comments until midnight Eastern Time
DEPARTMENT OF HEALTH AND Federal Register concerning each at the end of September 18, 2017.
HUMAN SERVICES proposed collection of information, Comments received by mail/hand
including each proposed extension of an delivery/courier (for written/paper
Food and Drug Administration submissions) will be considered timely
existing collection of information, and
if they are postmarked or the delivery
to allow 60 days for public comment in
[Docket No. FDA–2017–N–2428] service acceptance receipt is on or
response to the notice. This notice
before that date.
Agency Information Collection solicits comments on the information
Activities; Proposed Collection; collection provisions of FDA’s existing Electronic Submissions
reporting and recordkeeping
sradovich on DSK3GMQ082PROD with NOTICES
Comment Request; Animal Drug Submit electronic comments in the
Adverse Event Reporting and requirements for animal drug adverse following way:
Recordkeeping events and product/manufacturing • Federal eRulemaking Portal:
defects. https://www.regulations.gov. Follow the
AGENCY: Food and Drug Administration, instructions for submitting comments.
HHS. DATES: Submit either electronic or Comments submitted electronically,
written comments on the collection of including attachments, to https://
ACTION: Notice. information by September 18, 2017. www.regulations.gov will be posted to
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Document Created: 2018-10-24 11:23:38
Document Modified: 2018-10-24 11:23:38
| 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 August 17, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 32828 |
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