Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice, 19270-19271 [2021-07549]
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19270
Federal Register / Vol. 86, No. 69 / Tuesday, April 13, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1076]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
AGENCY:
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: Submit written comments
(including recommendations) on the
collection of information by May 13,
2021.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
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 0910–0563. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
Formal Dispute Resolution: Scientific
and Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice
OMB Control Number 0910–0563—
Extension
Section 562 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360bbb–1) directs FDA to establish
adequate dispute resolution (DR)
procedures to ensure appropriate review
of scientific controversies between FDA
and members of regulated industry,
including possible review by a scientific
advisory committee. To implement this
provision, we amended the general
appeal regulation applicable across all
FDA components (§ 10.75 (21 CFR
10.75)) to provide for advisory
committee review (§ 10.75(b)(2)). At the
same time and consistent with the
mandates of section 562 of the FD&C
Act, we adopted an approach whereby
specific implementation procedures
regarding scientific controversy
associated with review of certain FDA
decisions are detailed in center-issued
guidance.
Accordingly, we developed the
guidance for industry ‘‘Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice.’’
We intend that the guidance inform
manufacturers of veterinary and human
drugs, including human biological drug
products, on how to resolve disputes
about scientific and technical issues
relating to current good manufacturing
practice (CGMP).
Disputes related to scientific and
technical issues may arise during FDA
inspections of pharmaceutical
manufacturers to determine compliance
with CGMP requirements or during
FDA’s assessment of corrective actions
undertaken as a result of such
inspections. The guidance recommends
procedures that we believe encourage
open and prompt discussion of disputes
and lead to their resolution. The
guidance describes procedures for
raising such disputes to the Office of
Regulatory Affairs, and Center levels
and procedures for requesting review by
the DR panel. The guidance is available
on our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, along with
additional information regarding the
resolution of scientific disputes at FDA.
We estimate only a nominal burden
for the information collection and
assume that one manufacturer will
submit one request annually for tier-one
DR and that it will take manufacturers
approximately 30 hours to prepare and
submit each tier-one DR request. Since
our last request for OMB approval of the
information collection, we have
received no tier-two DRs.
In the Federal Register of December 9,
2020 (85 FR 79186), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total
hours
Requests for tier-one DR .....................................................
1
1
1
30
30
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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17:42 Apr 12, 2021
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Federal Register / Vol. 86, No. 69 / Tuesday, April 13, 2021 / Notices
Our estimated burden for the
information collection reflects a
decrease of 38 hours and a decrease of
1 request. This adjustment corresponds
to a decrease in the number of
submissions we have received over the
last few years.
Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07549 Filed 4–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0318]
Development Considerations of
Antimicrobial Drugs for the Treatment
of Gonorrhea; Public Workshop;
Request for Comments
Food and Drug Administration,
National Institute of Allergy and
Infectious Diseases, Centers for Disease
Control and Prevention, HHS.
ACTION: Notice of public workshop;
request for comments.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we),
the National Institute of Allergy and
Infectious Diseases (NIAID), and the
Centers for Disease Control and
Prevention (CDC) are announcing the
following public workshop entitled
‘‘Development Considerations of
Antimicrobial Drugs for the Treatment
of Gonorrhea.’’ The purpose of the
public workshop is to discuss the
nonclinical and clinical pharmacology
data and clinical trial design
considerations regarding developing
antimicrobial drugs for the treatment of
gonorrhea.
DATES: The public workshop will be
held virtually on April 23, 2021, from 9
a.m. to 5 p.m., Eastern Time. Submit
either electronic or written comments
on this public workshop by June 1,
2021. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held in virtual format only.
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 June 1, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 1, 2021. Comments received by
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SUMMARY:
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17:42 Apr 12, 2021
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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.
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.
• 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–
2021–N–0318 for ‘‘Development
Considerations of Antimicrobial Drugs
for the Treatment of Gonorrhea.’’
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
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19271
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-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: Lori
Benner and/or Antoinette Ziolkowski,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6221, Silver Spring,
MD 20993–0002, 301–796–1300.
I. Background
FDA, NIAID, and CDC are announcing
a public workshop regarding the
development considerations of
antimicrobial drugs for the treatment of
gonorrhea. As such, discussions will
focus on the current state of diagnosis
and treatment of gonorrhea and
nonclinical and clinical trial design
considerations for drug development.
II. Topics for Discussion at the Public
Workshop
The workshop will focus on
discussing challenges and clinical trial
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19270-19271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07549]
[[Page 19270]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1076]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Formal Dispute
Resolution: Scientific and Technical Issues Related to Pharmaceutical
Current Good Manufacturing Practice
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: Submit written comments (including recommendations) on the
collection of information by May 13, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://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 0910-0563. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Formal Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical Current Good Manufacturing Practice
OMB Control Number 0910-0563--Extension
Section 562 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360bbb-1) directs FDA to establish adequate dispute
resolution (DR) procedures to ensure appropriate review of scientific
controversies between FDA and members of regulated industry, including
possible review by a scientific advisory committee. To implement this
provision, we amended the general appeal regulation applicable across
all FDA components (Sec. 10.75 (21 CFR 10.75)) to provide for advisory
committee review (Sec. 10.75(b)(2)). At the same time and consistent
with the mandates of section 562 of the FD&C Act, we adopted an
approach whereby specific implementation procedures regarding
scientific controversy associated with review of certain FDA decisions
are detailed in center-issued guidance.
Accordingly, we developed the guidance for industry ``Formal
Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical Current Good Manufacturing Practice.'' We intend that
the guidance inform manufacturers of veterinary and human drugs,
including human biological drug products, on how to resolve disputes
about scientific and technical issues relating to current good
manufacturing practice (CGMP).
Disputes related to scientific and technical issues may arise
during FDA inspections of pharmaceutical manufacturers to determine
compliance with CGMP requirements or during FDA's assessment of
corrective actions undertaken as a result of such inspections. The
guidance recommends procedures that we believe encourage open and
prompt discussion of disputes and lead to their resolution. The
guidance describes procedures for raising such disputes to the Office
of Regulatory Affairs, and Center levels and procedures for requesting
review by the DR panel. The guidance is available on our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, along with additional information regarding the resolution
of scientific disputes at FDA.
We estimate only a nominal burden for the information collection
and assume that one manufacturer will submit one request annually for
tier-one DR and that it will take manufacturers approximately 30 hours
to prepare and submit each tier-one DR request. Since our last request
for OMB approval of the information collection, we have received no
tier-two DRs.
In the Federal Register of December 9, 2020 (85 FR 79186), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for tier-one DR........................................... 1 1 1 30 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 19271]]
Our estimated burden for the information collection reflects a
decrease of 38 hours and a decrease of 1 request. This adjustment
corresponds to a decrease in the number of submissions we have received
over the last few years.
Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07549 Filed 4-12-21; 8:45 am]
BILLING CODE 4164-01-P
