Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees, 16272-16274 [2023-05357]
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16272
ACTION:
Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
Notice.
Approval is withdrawn as of
April 17, 2023.
DATES:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of six abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
SUMMARY:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 065111 ...........................
Kanamycin Sulfate Injection, Equivalent to
(EQ) 500 milligrams (mg) base/2 milliliters
(mL) and EQ 1 gram (g) base/3 mL.
Levetiracetam Solution, 100 mg/mL ................
Nimodipine Capsules, 30 mg ...........................
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 079107 ...........................
ANDA 201832 ...........................
ANDA 202418 ...........................
Lamivudine and Zidovudine Tablets, 150 mg;
300 mg.
ANDA 202743 ...........................
Azelastine Hydrochloride (HCl), Metered
Spray, 0.2055 mg/spray.
ANDA 203937 ...........................
Fludeoxyglucose F18 Injection, 4–500 millicurie (mCi)/mL.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 17,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on April 17, 2023
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05360 Filed 3–15–23; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
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Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526.
Sofgen Pharmaceuticals, LCC, 21500 Biscayne Blvd., Suite
600, Aventura, FL 33180.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Ltd., 279 Princeton-Hightstown Rd., East Windsor,
NJ 08520.
Padagis US LLC., U.S. Agent for Padagis Israel Pharmaceuticals Ltd. (formerly known as Perrigo Israel Pharmaceuticals Ltd.), 3940 Quebec Avenue North, Minneapolis,
MN 55427.
Hot Shots NM, LLC, DBA Midwest Positron Technology, LC,
2017 E Kimberly Rd., Suite C, Davenport IA 52807.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Electronic Submissions
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
solicits comments on information
collection requirements contained in
regulations governing the use of
radioactive drugs for basic informational
research.
DATES: Either electronic or written
comments on the collection of
information must be submitted by May
15, 2023.
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 15, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ADDRESSES:
Sfmt 4703
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.
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
• 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–
2010–N–0583 for ‘‘Radioactive Drug
Research Committees.’’ 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, 240–402–7500.
• 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
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
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19:10 Mar 15, 2023
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the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
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16273
Radioactive Drug Research
Committees—21 CFR 361.1
OMB Control Number 0910–0053—
Extension
This information collection request
supports regulations and associated
Agency forms. Sections 201, 505, and
701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and
371) establish provisions under which
FDA issues regulations governing the
use of radioactive drugs for basic
scientific research. Specifically, section
§ 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 (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 FDA 2915
(Report on Research Use of Radioactive
Drugs—Study Summary).
We developed the guidance document
entitled ‘‘Radioactive Drug Research
Committee: Human Research Without
An Investigational New Drug
Application’’ (August 2010), available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/radioactive-drug-researchcommittee-human-research-withoutinvestigational-new-drug-application,
which provides information to help
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
determine whether research studies may
be conducted under an FDA-approved
RDRC, or whether research studies must
be conducted under an investigational
new drug application. It also offers
answers to frequently asked questions
on conducting research with radioactive
drugs, and provides information on the
membership, functions, and reporting
requirements of an RDRC approved by
FDA. All Agency guidance documents
are issued consistent with our good
guidance practice regulations at 21 CFR
10.115.
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
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.
We estimate the burden of this
collection of information as follows:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section and FDA form
Number of
responses per
respondent
Total annual
responses
Average burden
per response
(in hours)
Total hours
§ 361.1(c)(3) reports and (c)(4) approval (Form FDA 2914: Membership
Summary) 2.
§ 361.1(c)(3) reports (Form FDA 2915: Study Summary) 3 .....................
§ 361.1(d)(8) adverse events ...................................................................
56
1
56
1 ..................................
56
37
10
10
1
370
10
3 ..................................
0.5 (30 minutes) .........
1,110
5
Total ..................................................................................................
........................
........................
436
.....................................
1,171
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
3 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Total annual
records
Average burden per
recordkeeping
(in hours)
Total hours
§ 361.1(c)(2) RDRC ..................................................................................
§ 361.1(d)(5) human research subjects ...................................................
56
37
4
10
224
370
10 ................................
0.75 (45 minutes) .......
2,240
278
Total ..................................................................................................
........................
........................
594
.....................................
2,518
1
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Number of
records per
recordkeeper
There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our estimate for the
information collection to reflect an
annual decrease of 703 hours and 158
responses since OMB’s last approval.
We attribute this adjustment to a
decrease from 3.5 hours to 3 hours per
response for public reporting burden for
Form FDA–2915: Study Summary to
match the burden hours reflected on the
form. In addition, this adjustment is also
attributable to the Agency receiving
fewer submissions over the last few
years.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05357 Filed 3–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
SUMMARY:
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Sfmt 4703
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that LAMZEDE
(velmanase alfa-tycv), approved
February 16, 2023, and manufactured by
Chiesi Farmaceutici S.p.A., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
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]]>Agencies
[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16272-16274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0583]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Radioactive Drug Research Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 information collection requirements
contained in regulations governing the use of radioactive drugs for
basic informational research.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 15, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 15, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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.
[[Page 16273]]
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-2010-N-0583 for ``Radioactive Drug Research Committees.'' 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, 240-402-7500.
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
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Radioactive Drug Research Committees--21 CFR 361.1
OMB Control Number 0910-0053--Extension
This information collection request supports regulations and
associated Agency forms. Sections 201, 505, and 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371) establish
provisions under which FDA issues regulations governing the use of
radioactive drugs for basic scientific research. Specifically, section
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 (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
FDA 2915 (Report on Research Use of Radioactive Drugs--Study Summary).
We developed the guidance document entitled ``Radioactive Drug
Research Committee: Human Research Without An Investigational New Drug
Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help
[[Page 16274]]
determine whether research studies may be conducted under an FDA-
approved RDRC, or whether research studies must be conducted under an
investigational new drug application. It also offers answers to
frequently asked questions on conducting research with radioactive
drugs, and provides information on the membership, functions, and
reporting requirements of an RDRC approved by FDA. All Agency guidance
documents are issued consistent with our good guidance practice
regulations at 21 CFR 10.115.
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section and FDA form Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(3) reports and (c)(4) 56 1 56 1........................................ 56
approval (Form FDA 2914: Membership Summary)
\2\.
Sec. 361.1(c)(3) reports (Form FDA 2915: 37 10 370 3........................................ 1,110
Study Summary) \3\.
Sec. 361.1(d)(8) adverse events............ 10 1 10 0.5 (30 minutes)......................... 5
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Total.................................... .............. .............. 436 ......................................... 1,171
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping (in Total hours
recordkeepers recordkeeper records hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(2) RDRC...................... 56 4 224 10....................................... 2,240
Sec. 361.1(d)(5) human research subjects... 37 10 370 0.75 (45 minutes)........................ 278
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Total.................................... .............. .............. 594 ......................................... 2,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our estimate for the information collection to
reflect an annual decrease of 703 hours and 158 responses since OMB's
last approval. We attribute this adjustment to a decrease from 3.5
hours to 3 hours per response for public reporting burden for Form FDA-
2915: Study Summary to match the burden hours reflected on the form. In
addition, this adjustment is also attributable to the Agency receiving
fewer submissions over the last few years.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05357 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
