National Institute on Aging; Notice of Closed Meeting, 23693-23694 [2018-10933]
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Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
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.
Guidance for Industry: Controlled
Correspondence Related to Generic
Drug Development
OMB Control Number 0910–0797—
Extension
FDA has agreed to specific program
enhancements and performance goals
specified in the Generic Drug User Fee
Act Reauthorization (GDUFA II)
Commitment Letter. One of the
performance goals applies to controlled
correspondence related to generic drug
development. The GDUFA II
Commitment Letter includes details on
FDA’s commitment to respond to
questions submitted as controlled
correspondence within certain
timeframes. To support these program
goals, we have developed the guidance
entitled ‘‘Controlled Correspondence
Related to Generic Drug Development.’’
The guidance is intended to facilitate
FDA’s prompt consideration of
controlled correspondence and to assist
in meeting the prescribed timeframes by
providing procedural recommendations
to include the following information in
the inquiry: (1) Name, title, address,
phone number, and entity of the person
submitting the inquiry; (2) a letter of
authorization, if applicable; (3) the FDAassigned control number and
submission date of any previous, related
controlled correspondence that was
accepted for substantial review and
response, if any, as well as a copy of
that previous controlled correspondence
and FDA’s response, if any; (4) the
relevant reference listed drug(s), as
applicable, including the application
number, proprietary (brand) name,
manufacturer, active ingredient, dosage
form, and strength(s); (5) a statement
that the controlled correspondence is
related to a potential abbreviated new
drug application (ANDA) submission to
the Office of Generic Drugs and the
ANDA number, if applicable; (6) a
concise statement of the inquiry; (7) a
recommendation of the appropriate FDA
review discipline; and (8) relevant prior
research and supporting materials.
The GDUFA II Commitment Letter
also includes details on FDA’s
commitment to respond to requests to
clarify ambiguities in FDA’s controlled
correspondence response within certain
timeframes. To facilitate FDA’s prompt
consideration of the request and to
assist in meeting the prescribed
timeframes, the guidance recommends
including the following information in
the inquiry: (1) Name, title, address,
phone number, and entity of the person
submitting the inquiry; (2) a letter of
authorization, if applicable; (3) the FDAassigned control number, submission
date of the controlled correspondence
on which the requestor is seeking
clarification, a copy of that previous
controlled correspondence, and FDA’s
response to the controlled
correspondence; and (4) the clarifying
questions and the corresponding
section(s) of FDA’s controlled
correspondence response on which the
requestor is seeking clarification. This
information collection supports this
Agency guidance.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of controlled correspondence
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Generic drug manufacturers, related industry, and representatives ......................................................................
390
3.8
1,496
5
7,480
amozie on DSK3GDR082PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the
information collection and we base our
estimate on a review of Agency data of
fiscal year submissions for 2014, 2015,
and 2016 which reflects an increase in
submissions that we attribute to an
increase in generic drug development.
Accordingly, we estimate 390 generic
drug manufacturers and related industry
(e.g., contract research organizations
conducting bioanalytical or
bioequivalence clinical trials) or their
representatives will each submit an
average of 3.8 inquiries annually for a
total of 1,496 inquiries [1,496 ÷ 390 =
3.8]. Information submitted with each
inquiry varies widely in content,
depending on the complexity of the
request. Inquiries that are defined as
controlled correspondence may range
from a simple inquiry on generic drug
labeling to a more complex inquiry for
a formulation assessment for a specific
proposed generic drug product. As a
result, these inquiries can vary between
1 and 10 burden hours.
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Because the content of inquiries
considered controlled correspondence is
widely varied, we are providing an
average burden hour for each inquiry.
We estimate that it will take an average
of 5 hours per inquiry for industry to
gather necessary information, prepare
the request, and submit the request to
FDA. As a result, we estimate that it will
take an average of 7,480 total hours
annually for industry to prepare and
submit inquiries considered controlled
correspondence.
Dated: May 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10856 Filed 5–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel; Drug
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23694
Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
Repositioning and Combination Therapy for
AD.
Date: June 5, 2018.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Ave., Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute on Aging, Gateway Building 2C/212,
7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, parsadaniana@
nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: May 17, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–10933 Filed 5–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Eye Institute. The
meeting will be closed to the public as
indicated below in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL EYE INSTITUTE, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Eye Institute.
Date: June 11–13, 2018.
Time: 6:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate
programmatic concerns and personnel
qualifications.
Place: National Institutes of Health,
Building 31, Conference Room 6C10,
Bethesda, MD 20892.
Contact Person: Sheldon S. Miller, Ph.D.,
Scientific Director, National Institutes of
Health, National Eye Institute, Bethesda, MD
20892, (301) 451–6763, millerss@nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nei.nih.gov, where an agenda and any
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additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 16, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institute on Aging; Notice of
Closed Meeting
[FR Doc. 2018–10837 Filed 5–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NHLBI. The meeting will be
closed to the public as indicated below
in accordance with the provisions set
forth in section 552b(c)(6), Title 5
U.S.C., as amended for the review,
discussion, and evaluation of individual
intramural programs and projects
conducted by the National Heart, Lung,
and Blood Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NHLBI.
Date: June 15, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 10, 10 Center Drive, 6th Floor,
Room 6S233, Bethesda, MD 20892.
Contact Person: Robert S. Balaban, Ph.D.,
Scientific Director, Division of Intramural
Research, National Heart, Lung, and Blood
Institute, National Institutes of Health,
Building 10, 10 Center Drive, 4th Floor,
Room 1587, Bethesda, MD 20892, 301–496–
2116, balabanr@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: May 16, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–10836 Filed 5–21–18; 8:45 am]
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National Institutes of Health
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 on
Aging Special Emphasis Panel; Pragmatic
Trials for Dementia Care in Long Term
Services and Support.
Date: June 21, 2018.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Carmen, Ph.D. Moten,
MPH, Scientific Review Officer, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703, cmoten@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: May 17, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–10935 Filed 5–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
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[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23693-23694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10933]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on Aging Special Emphasis
Panel; Drug
[[Page 23694]]
Repositioning and Combination Therapy for AD.
Date: June 5, 2018.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, Suite
2W200, 7201 Wisconsin Ave., Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Alexander Parsadanian, Ph.D., Scientific Review
Officer, National Institute on Aging, Gateway Building 2C/212, 7201
Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: May 17, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-10933 Filed 5-21-18; 8:45 am]
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