Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 39913-39914 [2020-14262]
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–14332 Filed 7–1–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1360]
Teva Branded Pharmaceutical
Products R&D, Inc.; Withdrawal of
Approval of a New Drug Application for
ZECUITY (Sumatriptan Iontophoretic
Transdermal System)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
the approval of the new drug
application (NDA) for ZECUITY
(sumatriptan iontophoretic transdermal
system) held by Teva Branded
Pharmaceutical Products R&D, Inc.
(Teva), 41 Moores Rd., P.O. Box 4011,
Frazer, PA 19355. Teva requested
withdrawal of this application and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of July
2, 2020.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg., 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: On
January 17, 2013, FDA approved NDA
202278 for ZECUITY (sumatriptan
iontophoretic transdermal system) for
the acute treatment of migraine with or
without aura in adults. On June 2, 2016,
FDA issued a Drug Safety
Communication announcing the FDA is
investigating the risk of serious burns
and potential permanent scarring with
the use of ZECUITY for migraine
headaches. (https://www.fda.gov/drugs/
drug-safety-and-availability/fda-drugsafety-communication-fda-evaluatingrisk-burns-and-scars-ZECUITYsumatriptan-migraine-patch). On June
10, 2016, Teva suspended sales,
marketing and distribution to
investigate the cause of burns and scars
associated with ZECUITY.
On July 19, 2019, Teva requested
withdrawal of NDA 202278 for
ZECUITY under § 314.150(d) (21 CFR
314.150(d)) and waived its opportunity
for a hearing. In its letter requesting
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SUMMARY:
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withdrawal of approval, Teva stated that
it voluntarily discontinued manufacture
and sale of products under NDA 202278
in 2016 for commercial reasons and has
agreed to withdrawal of the application
for those reasons only.
For the reasons discussed above, and
pursuant to the applicant’s request,
approval of NDA 202278 for ZECUITY
(sumatriptan iontophoretic transdermal
system), and all amendments and
supplements thereto, is withdrawn
under § 314.150(d).
Distribution of ZECUITY into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14284 Filed 7–1–20; 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
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: Submit written comments
(including recommendations) on the
collection of information by August 3,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0053. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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39913
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 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.
FOR FURTHER INFORMATION CONTACT:
Radioactive Drug Research
Committees—21 CFR 361.1
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. This
information collection request supports
those regulations. Specifically, § 361.1
(21 CFR 361.1) sets forth specific
regulations about establishing and
composing radioactive drug research
committees (RDRCs) and their role in
approving and monitoring basic
research studies using
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 (§ 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 regulations and include
studies of metabolism, human
physiology, pathophysiology, or
biochemistry.
Section 361.1(c)(2) requires that each
RDRC will select a chairman, who will
sign all applications, minutes, and
reports of the committee. Each
committee will meet at least once each
quarter in which research activity has
been authorized or conducted. Minutes
will be kept and will include the
numerical results of votes on protocols
involving use in human subjects. Under
§ 361.1(c)(3), each RDRC will submit an
annual report to FDA. The annual report
will include the names and
qualifications of the members of and of
any consultants used by the RDRC,
using Form FDA 2914 entitled
‘‘Radioactive Drug Research Committee
Report on Research Use of Radioactive
Drugs Membership Summary.’’ The
annual report will also include a
summary of each study conducted
during the preceding year, using Form
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39914
Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
FDA 2915 entitled ‘‘Radioactive Drug
Research Committee Report on Research
Use of Radioactive Drugs Study
Summary.’’
Under § 361.1(d)(5), each investigator
will 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, based on a pregnancy
test, be confirmed as not pregnant.
Under § 361.1(d)(8), the investigator
will immediately report to the RDRC all
adverse effects associated with use of
the drug, and the committee will 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.
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 the regulations 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 or chairpersons of each
individual RDRC, investigators, and
participants in the studies. The burden
estimates are based on our experience
with these reporting and recordkeeping
requirements and the number of
submissions we received under the
regulations over the past 3 years.
In the Federal Register of January 21,
2020 (85 FR 3390), we published a 60day 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 2
Number of
respondents
21 CFR section and applicable form
§ 361.1(c)(3) reports and (c)(4) approval (Form FDA
2914: Membership Summary) 3.
§ 361.1(c)(3) reports (Form FDA 2915: Study Summary) 4.
§ 361.1(d)(8) adverse events .........................................
Total ........................................................................
Number of
responses per
respondent
Total
annual
responses
Average burden
per response
Total hours
62
1
62
1 ..........................
62
40
10
434
3.5 .......................
1,519
10
1
10
.5 (30 minutes) ....
5
........................
........................
506
.............................
1,586
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers may not sum due to rounding.
3 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
4 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
Number of
records per
recordkeepers
§ 361.1(c)(2) RDRC ........................................................
§ 361.1(d)(5) human research subjects .........................
62
40
4
10
248
434
10 ........................
.75 (45 minutes) ..
2,480
326
Total ........................................................................
........................
........................
682
.............................
2,806
21 CFR section
1 There
Total
annual
responses
Average
burden per
recordkeeping
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
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2 Numbers
We have adjusted our estimate for the
information collection to reflect an
annual decrease of 525 hours and 147
responses since last OMB review. This
adjustment corresponds to fewer
submissions we have received under the
information collection over the last few
years.
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14262 Filed 7–1–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
21:18 Jul 01, 2020
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
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
SUMMARY:
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exceptions or
Alternatives To Labeling Requirements
for Products Held by the Strategic
National Stockpile
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
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ACTION:
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]]>Agencies
[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39913-39914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14262]
-----------------------------------------------------------------------
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) 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: Submit written comments (including recommendations) on the
collection of information by August 3, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0053. 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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--21 CFR 361.1
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. This information collection request supports those
regulations. Specifically, Sec. 361.1 (21 CFR 361.1) sets forth
specific regulations about establishing and composing radioactive drug
research committees (RDRCs) and their role in approving and monitoring
basic research studies using 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 regulations and
include studies of metabolism, human physiology, pathophysiology, or
biochemistry.
Section 361.1(c)(2) requires that each RDRC will select a chairman,
who will sign all applications, minutes, and reports of the committee.
Each committee will meet at least once each quarter in which research
activity has been authorized or conducted. Minutes will be kept and
will include the numerical results of votes on protocols involving use
in human subjects. Under Sec. 361.1(c)(3), each RDRC will submit an
annual report to FDA. The annual report will include the names and
qualifications of the members of and of any consultants used by the
RDRC, using Form FDA 2914 entitled ``Radioactive Drug Research
Committee Report on Research Use of Radioactive Drugs Membership
Summary.'' The annual report will also include a summary of each study
conducted during the preceding year, using Form
[[Page 39914]]
FDA 2915 entitled ``Radioactive Drug Research Committee Report on
Research Use of Radioactive Drugs Study Summary.''
Under Sec. 361.1(d)(5), each investigator will 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, based on a pregnancy test, be confirmed as not pregnant.
Under Sec. 361.1(d)(8), the investigator will immediately report
to the RDRC all adverse effects associated with use of the drug, and
the committee will 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. 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 the regulations 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 or
chairpersons of each individual RDRC, investigators, and participants
in the studies. The burden estimates are based on our experience with
these reporting and recordkeeping requirements and the number of
submissions we received under the regulations over the past 3 years.
In the Federal Register of January 21, 2020 (85 FR 3390), we
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\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section and applicable form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(3) reports and (c)(4) approval 62 1 62 1....................................... 62
(Form FDA 2914: Membership Summary) \3\.
Sec. 361.1(c)(3) reports (Form FDA 2915: 40 10 434 3.5..................................... 1,519
Study Summary) \4\.
Sec. 361.1(d)(8) adverse events............. 10 1 10 .5 (30 minutes)......................... 5
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. 506 ........................................ 1,586
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\4\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeepers responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(2) RDRC....................... 62 4 248 10...................................... 2,480
Sec. 361.1(d)(5) human research subjects.... 40 10 434 .75 (45 minutes)........................ 326
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. 682 ........................................ 2,806
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
We have adjusted our estimate for the information collection to
reflect an annual decrease of 525 hours and 147 responses since last
OMB review. This adjustment corresponds to fewer submissions we have
received under the information collection over the last few years.
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14262 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P
