National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 7474-7475 [2022-02660]
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Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices
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.
Generic Drug User Fee Program
OMB Control Number 0910–0727—
Revision
This information collection supports
implementation of FDA’s Generic Drug
User Fee program. The Generic Drug
User Fee Amendments (GDUFA) (Pub.
L. 112–144, Title 111) were enacted to
speed the delivery of safe and effective
generic drugs to the public and reduce
costs to industry. GDUFA authorizes
FDA to assess user fees to fund critical
and measurable enhancements to the
performance of FDA’s generic drugs
program, bringing greater predictability
and timeliness to the review of generic
drug applications. GDUFA is currently
authorized through September 30, 2022,
with reauthorization activities currently
underway. For more information
regarding GDUFA and ongoing
implementation, we invite you to visit
our website at https://www.fda.gov/
industry/fda-user-fee-programs/genericdrug-user-fee-amendments.
GDUFA is based on an agreement
negotiated by FDA and representatives
of the generic drug industry intended to
address continuing regulatory
challenges. GDUFA reflects input
received during an open process that
includes regular public meetings,
posting of meeting minutes, and
consideration of comments from a
public docket. We are revising the
information collection to include the
current GDUFA agreement, or ‘‘goals
letter,’’ as reflected in the document
‘‘GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal
Years 2018–2022,’’ available for
download from our website at https://
www.fda.gov/media/101052/download.
The performance goals and program
enhancements specified in the goals
letter apply to aspects of the generic
drug review program that are important
for facilitating timely access to quality,
affordable generic medicines. FDA is
committed to meeting the performance
goals specified in the goals letter and to
continuous improvement of its
performance.
Included among the performance
goals is the issuance of topic-specific
guidance documents. We maintain a
searchable guidance database on our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents. In publishing the
respective notices of availability for
each guidance document, we include an
analysis under the PRA and invite
public comment on the associated
information collection
recommendations. In addition, all
Agency guidance documents are issued
in accordance with our Good Guidance
Practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
We have developed Form FDA 3794,
the Generic Drug User Fee Cover Sheet,
available at https://www.fda.gov/
industry/fda-user-fee-programs which
requests the minimum necessary
information from generic drug
applicants to account for and track user
fees and to determine the amount of the
fee required. Applicants complete and
submit the cover sheets to accompany
payments. While applicants may submit
payment through multiple means, all
cover sheets are prepared using FDA’s
web-based electronic User Fee System.
Upon submitting the completed cover
sheet, the User Fee System generates a
user fee identification number, which is
provided to applicants at the bottom of
the cover sheet. It also notes the correct
fiscal year user fee assessment that is
due for the submission or program. FDA
requests that applicants submit a copy
of this completed cover sheet along with
the abbreviated new drug application, as
well as other additional GDUFA fees, so
FDA can verify that the applicant has
paid the correct user fee and their
account is current.
Respondents to the information
collection are potential or actual generic
drug application holders or related
active pharmaceutical ingredient and
finished dosage form manufacturers.
Companies with multiple user fee
obligations may submit a cover sheet for
each user fee obligation.
In the Federal Register of November
19, 2021 (86 FR 64945), 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 BURDEN1
Number of
respondents
Form FDA 3794
Generic Drug User Fee Cover Sheet ..........................
1 There
500
Total annual
responses
7.616
3,808
Average burden
per response
0.5(30 minutes) ......
Total hours
1,904
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we have retained the
currently approved burden estimate.
Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02689 Filed 2–8–22; 8:45 am]
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Number of
responses per
respondent
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID New Innovators
Awards (DP2 Clinical Trial Not Allowed).
Date: March 10–11, 2022.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Brenda Lange-Gustafson,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41B,
Rockville, MD 20852, (240) 669–5047,
bgustafson@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: February 3, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
20852, 301–761–6911, anuja.mathew@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS).
Dated: February 3, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–02661 Filed 2–8–22; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2022–0050]
[FR Doc. 2022–02660 Filed 2–8–22; 8:45 am]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0005
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Coast Guard, DHS.
Sixty-Day notice requesting
comments.
AGENCY:
ACTION:
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel; NIAID, Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required) and NIAID Clinical
Trial Planning Grants (R34 Clinical Trial Not
Allowed).
Date: March 4, 2022.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G58,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Anuja Mathew, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G58, Rockville, MD
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In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0005, Application and Permit to
Handle Hazardous Materials; without
change. Our ICR describes the
information we seek to collect from the
public. Before submitting this ICR to
OIRA, the Coast Guard is inviting
comments as described below.
DATES: Comments must reach the Coast
Guard on or before April 11, 2022.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2022–0050] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from:
COMMANDANT (CG–6P), ATTN:
PAPERWORK REDUCTION ACT
MANAGER, U.S. COAST GUARD, 2703
MARTIN LUTHER KING JR. AVE. SE,
STOP 7710, WASHINGTON, DC 20593–
7710.
FOR FURTHER INFORMATION CONTACT: A.L.
Craig, Office of Privacy Management,
SUMMARY:
National Institute of Allergy and
Infectious Diseases Notice of Closed
Meeting
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7475
telephone 202–475–3528, or fax 202–
372–8405, for questions on these
documents.
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. 3501 et seq., chapter 35, as
amended. An ICR is an application to
OIRA seeking the approval, extension,
or renewal of a Coast Guard collection
of information (Collection). The ICR
contains information describing the
Collection’s purpose, the Collection’s
likely burden on the affected public, an
explanation of the necessity of the
Collection, and other important
information describing the Collection.
There is one ICR for each Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology.
In response to your comments, we
may revise this ICR or decide not to seek
an extension of approval for the
Collection. We will consider all
comments and material received during
the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
ICR and the docket number of this
request, [USCG–2022–0050], and must
be received by April 11, 2022.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
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]]>Agencies
[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7474-7475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02660]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel NIAID New Innovators Awards (DP2
Clinical Trial Not Allowed).
Date: March 10-11, 2022.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 7475]]
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Brenda Lange-Gustafson, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41B,
Rockville, MD 20852, (240) 669-5047, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: February 3, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-02660 Filed 2-8-22; 8:45 am]
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