Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 26046-26047 [2021-09968]
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26046
Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
antibacterial and antifungal drugs for
human use to treat serious or lifethreatening infections. The primary
incentive contained in GAIN is a 5-year
extension of exclusivity for which a
QIDP-designated application qualifies
upon approval under the FD&C Act.
QIDPs also receive fast-track designation
at the sponsor’s request (21 U.S.C.
356(b)(1)), and the first marketing
application submitted for approval of a
QIDP is granted priority review (21
U.S.C. 360n–1).
This guidance provides information
about how FDA generally intends to
implement GAIN and responses to
common questions that might arise
about QIDP designation and review of
new drug applications for QIDPs.
This guidance finalizes the draft
guidance of the same name issued on
January 30, 2018 (83 FR 4216). Based on
the comments submitted to the docket
on the draft guidance, FDA made
clarifying changes to this guidance,
including further information on what
drug products the Agency generally
intends to consider to be an
antibacterial or antifungal drug for the
purposes of QIDP designation. The
Agency also provided clarification about
when a sponsor should submit a new
request for QIDP designation and what
information should be included in a
QIDP designation request.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on QIDP designation. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09986 Filed 5–11–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0074]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
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 June 11,
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
SUMMARY:
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 0910–0275. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
State Enforcement Notifications—21
CFR 100.2(d)
OMB Control Number 0910–0275—
Extension
This information collection supports
Agency regulations. Specifically, section
310(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
337(b)) authorizes a State to enforce
certain sections of the FD&C Act in its
own name and within its own
jurisdiction. However, before doing so,
a State must provide notice to FDA
according to § 100.2 (21 CFR 100.2). The
information required in a letter of
notification under § 100.2(d) enables us
to identify the food against which a
State intends to take action and to
advise that State whether Federal
enforcement action against the food has
been taken or is in process. With certain
narrow exceptions, Federal enforcement
action precludes State action under the
FD&C Act.
In the Federal Register of December
17, 2020 (85 FR 81932), FDA 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:
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.2(d) ................................................................................
1
1
1
10
10
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
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17:58 May 11, 2021
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OMB approval, we have made no
adjustments to our burden estimate.
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The estimated reporting burden for
§ 100.2(d) is minimal because
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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
enforcement notifications are seldom
used by States. During the last 3 years,
we have not received any new
enforcement notifications; therefore, we
estimate that one or fewer notifications
will be submitted annually. Although
we have not received any new
enforcement notifications in the last 3
years, we believe these information
collection provisions should be
extended to provide for the potential
future need of a State government to
submit enforcement notifications
informing us when it intends to take
enforcement action under the FD&C Act
against a particular food located in the
State.
Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09968 Filed 5–11–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6113]
E9(R1) Statistical Principles for Clinical
Trials: Addendum: Estimands and
Sensitivity Analysis in Clinical Trials;
International Council for
Harmonisation; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘E9(R1)
Statistical Principles for Clinical Trials:
Addendum: Estimands and Sensitivity
Analysis in Clinical Trials.’’ The
guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The guidance clarifies,
updates, and extends the guidance for
industry ‘‘E9 Statistical Principles for
Clinical Trials’’ issued in September
1998 in two main areas. Concerning
estimands, it provides a framework for
discussion of how the aims of a trial
relate to the proposed statistical
analysis. Concerning sensitivity
analysis, it discusses how to use
additional analyses to address concerns
about the validity of assumptions
underlying the main analysis. The
guidance is intended to better align the
choice of statistical methods with
questions of regulatory importance and
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:58 May 11, 2021
Jkt 253001
so to improve the reliability of decisions
about and representations of the effects
of medical products. The guidance
replaces the draft guidance issued on
October 31, 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on May 12, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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–
2017–D–6113 for ‘‘E9(R1) Statistical
Principles for Clinical Trials:
Addendum: Estimands and Sensitivity
Analysis in Clinical Trials.’’ Received
comments will be placed in the docket
and, except for those submitted as
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26047
‘‘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-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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
E:\FR\FM\12MYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26046-26047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09968]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0074]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
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 June 11, 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 0910-0275. 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.
State Enforcement Notifications--21 CFR 100.2(d)
OMB Control Number 0910-0275--Extension
This information collection supports Agency regulations.
Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain
sections of the FD&C Act in its own name and within its own
jurisdiction. However, before doing so, a State must provide notice to
FDA according to Sec. 100.2 (21 CFR 100.2). The information required
in a letter of notification under Sec. 100.2(d) enables us to identify
the food against which a State intends to take action and to advise
that State whether Federal enforcement action against the food has been
taken or is in process. With certain narrow exceptions, Federal
enforcement action precludes State action under the FD&C Act.
In the Federal Register of December 17, 2020 (85 FR 81932), FDA
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d)........................................................... 1 1 1 10 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
The estimated reporting burden for Sec. 100.2(d) is minimal
because
[[Page 26047]]
enforcement notifications are seldom used by States. During the last 3
years, we have not received any new enforcement notifications;
therefore, we estimate that one or fewer notifications will be
submitted annually. Although we have not received any new enforcement
notifications in the last 3 years, we believe these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing us when it intends to take enforcement action under the FD&C
Act against a particular food located in the State.
Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09968 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P
