83 FR 23693 - National Institute on Aging; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 99 (May 22, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 99 (May 22, 2018)
| Page Range | 23693-23694 | |
| FR Document | 2018-10933 |
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)] [Notices] [Pages 23693-23694] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10933] ----------------------------------------------------------------------- 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] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices 23693
information to be collected; and (4) FDA’s prompt consideration of The GDUFA II Commitment Letter
ways to minimize the burden of the controlled correspondence and to assist also includes details on FDA’s
collection of information on in meeting the prescribed timeframes by commitment to respond to requests to
respondents, including through the use providing procedural recommendations clarify ambiguities in FDA’s controlled
of automated collection techniques, to include the following information in correspondence response within certain
when appropriate, and other forms of the inquiry: (1) Name, title, address, timeframes. To facilitate FDA’s prompt
information technology. phone number, and entity of the person consideration of the request and to
Guidance for Industry: Controlled submitting the inquiry; (2) a letter of assist in meeting the prescribed
Correspondence Related to Generic authorization, if applicable; (3) the FDA- timeframes, the guidance recommends
Drug Development assigned control number and including the following information in
submission date of any previous, related the inquiry: (1) Name, title, address,
OMB Control Number 0910–0797— controlled correspondence that was phone number, and entity of the person
Extension accepted for substantial review and submitting the inquiry; (2) a letter of
FDA has agreed to specific program response, if any, as well as a copy of authorization, if applicable; (3) the FDA-
enhancements and performance goals that previous controlled correspondence assigned control number, submission
specified in the Generic Drug User Fee and FDA’s response, if any; (4) the date of the controlled correspondence
Act Reauthorization (GDUFA II) relevant reference listed drug(s), as on which the requestor is seeking
Commitment Letter. One of the applicable, including the application
clarification, a copy of that previous
performance goals applies to controlled number, proprietary (brand) name,
controlled correspondence, and FDA’s
correspondence related to generic drug manufacturer, active ingredient, dosage
response to the controlled
development. The GDUFA II form, and strength(s); (5) a statement
correspondence; and (4) the clarifying
Commitment Letter includes details on that the controlled correspondence is
related to a potential abbreviated new questions and the corresponding
FDA’s commitment to respond to
drug application (ANDA) submission to section(s) of FDA’s controlled
questions submitted as controlled
the Office of Generic Drugs and the correspondence response on which the
correspondence within certain
timeframes. To support these program ANDA number, if applicable; (6) a requestor is seeking clarification. This
goals, we have developed the guidance concise statement of the inquiry; (7) a information collection supports this
entitled ‘‘Controlled Correspondence recommendation of the appropriate FDA Agency guidance.
Related to Generic Drug Development.’’ review discipline; and (8) relevant prior We estimate the burden of the
The guidance is intended to facilitate research and supporting materials. information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Submission of controlled correspondence responses per burden per Total hours
respondents responses
respondent response
Generic drug manufacturers, related industry, and rep-
resentatives ...................................................................... 390 3.8 1,496 5 7,480
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the Because the content of inquiries DEPARTMENT OF HEALTH AND
information collection and we base our considered controlled correspondence is HUMAN SERVICES
estimate on a review of Agency data of widely varied, we are providing an
fiscal year submissions for 2014, 2015, average burden hour for each inquiry. National Institutes of Health
and 2016 which reflects an increase in We estimate that it will take an average
National Institute on Aging; Notice of
submissions that we attribute to an of 5 hours per inquiry for industry to
Closed Meeting
increase in generic drug development. gather necessary information, prepare
Accordingly, we estimate 390 generic the request, and submit the request to Pursuant to section 10(d) of the
drug manufacturers and related industry FDA. As a result, we estimate that it will Federal Advisory Committee Act, as
(e.g., contract research organizations take an average of 7,480 total hours amended, notice is hereby given of the
conducting bioanalytical or annually for industry to prepare and following meeting.
bioequivalence clinical trials) or their submit inquiries considered controlled The meeting will be closed to the
representatives will each submit an correspondence. public in accordance with the
average of 3.8 inquiries annually for a Dated: May 16, 2018. provisions set forth in sections
total of 1,496 inquiries [1,496 ÷ 390 = 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Leslie Kux,
3.8]. Information submitted with each as amended. The grant applications and
Associate Commissioner for Policy.
inquiry varies widely in content, the discussions could disclose
[FR Doc. 2018–10856 Filed 5–21–18; 8:45 am]
depending on the complexity of the confidential trade secrets or commercial
request. Inquiries that are defined as BILLING CODE 4164–01–P
property such as patentable material,
amozie on DSK3GDR082PROD with NOTICES1
controlled correspondence may range and personal information concerning
from a simple inquiry on generic drug individuals associated with the grant
labeling to a more complex inquiry for applications, the disclosure of which
a formulation assessment for a specific would constitute a clearly unwarranted
proposed generic drug product. As a invasion of personal privacy.
result, these inquiries can vary between Name of Committee: National Institute on
1 and 10 burden hours. 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 additional information for the meeting will DEPARTMENT OF HEALTH AND
AD. be posted when available. HUMAN SERVICES
Date: June 5, 2018. (Catalogue of Federal Domestic Assistance
Time: 11:00 a.m. to 2:00 p.m. Program Nos. 93.867, Vision Research, National Institutes of Health
Agenda: To review and evaluate grant National Institutes of Health, HHS)
applications. National Institute on Aging; Notice of
Place: National Institute on Aging, Dated: May 16, 2018.
Natasha M. Copeland,
Closed Meeting
Gateway Building, Suite 2W200, 7201
Wisconsin Ave., Bethesda, MD 20892 Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the
(Telephone Conference Call). Committee Policy. Federal Advisory Committee Act, as
Contact Person: Alexander Parsadanian, [FR Doc. 2018–10837 Filed 5–21–18; 8:45 am] amended, notice is hereby given of the
Ph.D., Scientific Review Officer, National BILLING CODE 4140–01–P following meeting.
Institute on Aging, Gateway Building 2C/212, The meeting will be closed to the
7201 Wisconsin Avenue, Bethesda, MD
public in accordance with the
20892, 301–496–9666, parsadaniana@
nia.nih.gov.
DEPARTMENT OF HEALTH AND provisions set forth in sections
HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research, as amended. The grant applications and
National Institutes of Health the discussions could disclose
National Institutes of Health, HHS)
confidential trade secrets or commercial
Dated: May 17, 2018. National Heart, Lung, and Blood property such as patentable material,
David D. Clary, Institute; Notice of Meeting and personal information concerning
Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the individuals associated with the grant
Committee Policy. applications, the disclosure of which
Federal Advisory Committee Act, as
[FR Doc. 2018–10933 Filed 5–21–18; 8:45 am] would constitute a clearly unwarranted
amended, notice is hereby given of a
BILLING CODE 4140–01–P meeting of the Board of Scientific invasion of personal privacy.
Counselors, NHLBI. The meeting will be Name of Committee: National Institute on
closed to the public as indicated below Aging Special Emphasis Panel; Pragmatic
DEPARTMENT OF HEALTH AND in accordance with the provisions set Trials for Dementia Care in Long Term
HUMAN SERVICES forth in section 552b(c)(6), Title 5 Services and Support.
U.S.C., as amended for the review, Date: June 21, 2018.
National Institutes of Health Time: 1:00 p.m. to 4:30 p.m.
discussion, and evaluation of individual
Agenda: To review and evaluate grant
National Eye Institute; Notice of Closed intramural programs and projects applications.
Meeting conducted by the National Heart, Lung, Place: National Institute on Aging,
and Blood Institute, including Gateway Building, Suite 2W200, 7201
Pursuant to section 10(d) of the consideration of personnel Wisconsin Avenue, Bethesda, MD 20892
Federal Advisory Committee Act, as qualifications and performance, and the (Telephone Conference Call).
amended, notice is hereby given of a competence of individual investigators, Contact Person: Carmen, Ph.D. Moten,
meeting of the Board of Scientific the disclosure of which would MPH, Scientific Review Officer, National
constitute a clearly unwarranted Institute on Aging, Gateway Building, 7201
Counselors, National Eye Institute. The
Wisconsin Avenue, Suite 2C212, Bethesda,
meeting will be closed to the public as invasion of personal privacy.
MD 20892, 301–402–7703, cmoten@
indicated below in accordance with the Name of Committee: Board of Scientific mail.nih.gov.
provisions set forth in section Counselors, NHLBI. (Catalogue of Federal Domestic Assistance
552b(c)(6), Title 5 U.S.C., as amended Date: June 15, 2018. Program Nos. 93.866, Aging Research,
for the review, discussion, and Time: 8:00 a.m. to 5:00 p.m. National Institutes of Health, HHS)
evaluation of individual intramural Agenda: To review and evaluate personal
qualifications and performance, and Dated: May 17, 2018.
programs and projects conducted by the
competence of individual investigators. David D. Clary,
NATIONAL EYE INSTITUTE, including
Place: National Institutes of Health, Program Analyst, Office of Federal Advisory
consideration of personnel Building 10, 10 Center Drive, 6th Floor, Committee Policy.
qualifications and performance, and the Room 6S233, Bethesda, MD 20892.
competence of individual investigators, [FR Doc. 2018–10935 Filed 5–21–18; 8:45 am]
Contact Person: Robert S. Balaban, Ph.D.,
the disclosure of which would Scientific Director, Division of Intramural BILLING CODE 4140–01–P
constitute a clearly unwarranted Research, National Heart, Lung, and Blood
invasion of personal privacy. Institute, National Institutes of Health,
Building 10, 10 Center Drive, 4th Floor, DEPARTMENT OF HEALTH AND
Name of Committee: Board of Scientific HUMAN SERVICES
Room 1587, Bethesda, MD 20892, 301–496–
Counselors, National Eye Institute.
2116, balabanr@nhlbi.nih.gov.
Date: June 11–13, 2018. National Institutes of Health
Time: 6:00 p.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
Agenda: To review and evaluate Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and Center for Scientific Review; Notice of
programmatic concerns and personnel
Vascular Diseases Research; 93.838, Lung Closed Meetings
qualifications.
Place: National Institutes of Health, Diseases Research; 93.839, Blood Diseases
Pursuant to section 10(d) of the
Building 31, Conference Room 6C10, and Resources Research, National Institutes
Federal Advisory Committee Act, as
amozie on DSK3GDR082PROD with NOTICES1
Bethesda, MD 20892. of Health, HHS)
amended, notice is hereby given of the
Contact Person: Sheldon S. Miller, Ph.D., Dated: May 16, 2018. following meetings.
Scientific Director, National Institutes of Michelle D. Trout,
Health, National Eye Institute, Bethesda, MD
The meetings will be closed to the
20892, (301) 451–6763, millerss@nih.gov. Program Analyst, Office of Federal Advisory public in accordance with the
Information is also available on the Committee Policy. provisions set forth in sections
Institute’s/Center’s home page: [FR Doc. 2018–10836 Filed 5–21–18; 8:45 am] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
www.nei.nih.gov, where an agenda and any BILLING CODE 4140–01–P as amended. The grant applications and
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Document Created: 2018-11-02 11:10:10
Document Modified: 2018-11-02 11:10:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | June 5, 2018. | |
| FR Citation | 83 FR 23693 |
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