83 FR 10863 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 49 (March 13, 2018)

Page Range		10863-10864
FR Document		2018-04961

Federal Register, Volume 83 Issue 49 (Tuesday, March 13, 2018)

[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10863-10864]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04961]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; 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 the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning

[[Page 10864]]

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 Child Health and Human 
Development Special Emphasis Panel--R41 applications.
    Date: April 4, 2018.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6710B Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health and Human Development, National Institutes of Health, 
6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-6680, 
[email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel.
    Date: April 9, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave, 
Bethesda, MD 20814.
    Contact Person: Kimberly Lynette Houston, MD, Scientific Review 
Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, DHHS, 
National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 
20892, 301.827.4902, [email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel.
    Date: April 10, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave, 
Bethesda, MD 20814.
    Contact Person: Kimberly Lynette Houston, MD, Scientific Review 
Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, DHHS, 
National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 
20892, 301.827.4902, [email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel.
    Date: April 10, 2018.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, 6710B Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health and Human Development, 6710B Rockledge Drive, Bethesda, 
MD 20892, (301) 435-6680, [email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel.
    Date: April 13, 2018.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Peter Zelazowski, Ph.D., Scientific Review 
Officer, Division of Scientific Review, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, 6710B 
Rockledge Drive, Bethesda, MD 20892-7510, 301-435-6902, 
[email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel.
    Date: April 16-17, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health and Human Development, NIH, 6710B Rockledge Drive, 
Bethesda, MD 20892, (301) 435-6884, [email protected].

(Research for Mothers and Children; 93.929, Center for Medical 
Rehabilitation Research; 93.209, Contraception and Infertility Loan 
Repayment Program, National Institutes of Health, HHS)

    Dated: March 7, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-04961 Filed 3-12-18; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 49 / Tuesday, March 13, 2018 / Notices 10863

Because listing outside of the annual Dated: March 7, 2018. description of the oral presentation. Only one
requirement is voluntary, FDA estimates Leslie Kux, representative of an organization may be
that annually 78 percent of 510(k)s will Associate Commissioner for Policy. allowed to present oral comments and if
accepted by the committee, presentations
continue to be listed outside of the [FR Doc. 2018–04995 Filed 3–12–18; 8:45 am] may be limited to five minutes. Both printed
annual requirement. FDA estimates that BILLING CODE 4164–01–P and electronic copies are requested for the
4,080 510(k)s may be listed outside of record. In addition, any interested person
the annual registration cycle. FDA may file written comments with the
estimates that it will take approximately DEPARTMENT OF HEALTH AND committee by forwarding their statement to
15 minutes for each listing, for a total HUMAN SERVICES the Contact Person listed on this notice. The
reporting burden of 1,020 hours. statement should include the name, address,
FDA estimates it will have 2,033 National Institutes of Health telephone number and when applicable, the
instances of more than one party business or professional affiliation of the
claiming to be a 510(k) holder for a Office of the Director, National interested person.
Institutes of Health; Notice of Meeting In the interest of security, NIH has
specific device as part of annual instituted stringent procedures for entrance
registration and listing. FDA reached Pursuant to section 10(d) of the onto the NIH campus. All visitor vehicles,
this estimate by identifying the number Federal Advisory Committee Act, as including taxicabs, hotel, and airport shuttles
of unique 510(k) device listings entered amended, notice is hereby given of a will be inspected before being allowed on
in FURLS between fiscal years 2009 and meeting of the Advisory Committee on campus. Visitors will be asked to show one
2014 that conflict with a listing already Research on Women’s Health. form of identification (for example, a
entered by another party (5,304), government-issued photo ID, driver’s license,
The meeting will be open to the or passport) and to state the purpose of their
dividing that number by the number of public as indicated below, with
years (6), and multiplying by the visit.
attendance limited to space available. Information is also available on the
average number of parties claiming to be Individuals who plan to attend and Institute’s/Center’s home page:
the 510(k) holder when there is a need special assistance, such as sign www4.od.nih.gov/orwh/, where an agenda
conflict in the current FURLS database language interpretation or other and any additional information for the
(2.3). The draft guidance identifies reasonable accommodations, should meeting will be posted when available.
potential documentation a party could notify the Contact Person listed below (Catalogue of Federal Domestic Assistance
submit to FDA to establish the transfer in advance of the meeting. Program Nos. 93.14, Intramural Research
of a 510(k) clearance. FDA estimates it A portion of the meeting will be Training Award; 93.22, Clinical Research
will take a party approximately 4 hours closed to the public in accordance with Loan Repayment Program for Individuals
to locate and submit information to from Disadvantaged Backgrounds; 93.232,
the provisions set forth in sections Loan Repayment Program for Research
establish the transfer of the 510(k) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
clearance, resulting in 8,132 burden Generally; 93.39, Academic Research
as amended. The grant applications and Enhancement Award; 93.936, NIH Acquired
hours for those 2,033 parties claiming to the discussions could disclose Immunodeficiency Syndrome Research Loan
be 510(k) holders. FDA reached this confidential trade secrets or commercial Repayment Program; 93.187, Undergraduate
estimate based on its expectation of the property such as patentable material, Scholarship Program for Individuals from
amount of time it will take a party to and personal information concerning Disadvantaged Backgrounds, National
locate the information, copy it, and individuals associated with the grant Institutes of Health, HHS)
submit a copy to FDA. applications, the disclosure of which Dated: March 6, 2018.
The burden estimate does not include
would constitute a clearly unwarranted Michelle Trout,
the maintenance of records used to
invasion of personal privacy. Program Analyst, Office of Federal Advisory
document transferring a premarket
notification (510(k)) clearance. Based on Name of Committee: Advisory Committee Committee Policy.
available information, FDA believes that on Research on Women’s Health. [FR Doc. 2018–04954 Filed 3–12–18; 8:45 am]
Closed: April 17, 2018, 2:30 p.m. to 4:45
the maintenance of these records is a BILLING CODE 4140–01–P
p.m.
usual and customary part of normal Agenda: To evaluate the Sex/Gender
business activities. For example, in the Administrative Supplements program
ordinary course of business, supporting proposed for ORWH’s Strategic Plan. DEPARTMENT OF HEALTH AND
documents should be kept to verify Open: April 18, 2018, 9:00 a.m. to 1:30 HUMAN SERVICES
asset information for calculating the p.m.
annual depreciation or calculating gain Agenda: Opening Remarks, Director’s National Institutes of Health
or loss on sale of an asset on a Report, NIH Legislative Update, Strategic
Plan Update, and Scientific Presentations. Eunice Kennedy Shriver National
businesses’ tax return. Therefore, this Institute of Child Health and Human
Place: National Institutes of Health,
recordkeeping requirement creates no Building 31, 6th Floor, Conference Room 10, Development; Notice of Closed
additional paperwork burden. 31 Center Drive, Bethesda, MD 20892. Meetings
The draft guidance also refers to Contact Person: Elizabeth Spencer, R.N.,
previously approved collections of Deputy Director, Office of Research on Pursuant to section 10(d) of the
information found in FDA regulations. Women’s Health, Executive Secretary, Federal Advisory Committee Act, as
The collections of information in 21 ACRWH, National Institutes of Health, 6707 amended, notice is hereby given of the
CFR part 807 (registration and listing) Democracy Blvd., Room 7W444, Bethesda, following meetings.
are approved under OMB control MD 20817, 301–402–1770 elizabeth.spencer@ The meetings will be closed to the
number 0910–0625; the collections of nih.gov. public in accordance with the
amozie on DSK30RV082PROD with NOTICES

information in 21 CFR part 807 subpart Any member of the public interested in provisions set forth in sections
E (premarket notification submission) presenting oral comments to the committee 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
may notify the Contact Person listed on this
have been approved under OMB control notice at least 10 days in advance of the
as amended. The grant applications and
number 0910–0120, and collections of meeting. Interested individuals and the discussions could disclose
information in 42 CFR 493.17 have been representatives of organizations may submit confidential trade secrets or commercial
approved under OMB control number a letter of intent, a brief description of the property such as patentable material,
0910–0607. organization represented, and a short and personal information concerning

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10864 Federal Register / Vol. 83, No. 49 / Tuesday, March 13, 2018 / Notices

individuals associated with the grant Date: April 13, 2018. with Title 5 U.S.C § 552b(c)(4) and (6)
applications, the disclosure of which Time: 8:30 a.m. to 5:00 p.m. and Title 5 U.S.C. App. 2, 10(d).
would constitute a clearly unwarranted Agenda: To review and evaluate grant Meeting information and a roster of
applications. Council members may be obtained by
invasion of personal privacy.
Place: Residence Inn Bethesda, 7335
Name of Committee: National Institute of accessing the SAMHSA Committee
Wisconsin Avenue, Bethesda, MD 20814.
Child Health and Human Development Contact Person: Peter Zelazowski, Ph.D.,
website at http://www.samhsa.gov/
Special Emphasis Panel—R41 applications. Scientific Review Officer, Division of about-us/advisory-councils/csat-
Date: April 4, 2018. Scientific Review, Eunice Kennedy Shriver national-advisory-council or by
Time: 1:00 p.m. to 4:00 p.m. National Institute of Child Health and contacting the CSAT National Advisory
Agenda: To review and evaluate grant Human Development, NIH, 6710B Rockledge Council Designated Federal Officer;
applications. Drive, Bethesda, MD 20892–7510, 301–435– Tracy Goss (see contact information
Place: National Institutes of Health, 6710B 6902, peter.zelazowski@nih.gov. below).
Rockledge Drive, Bethesda, MD 20892
Name of Committee: National Institute of Council Name: SAMHSA’s Center for
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Child Health and Human Development Substance Abuse Treatment National
Ph.D., Scientific Review Administrator, Special Emphasis Panel. Advisory Council.
Division of Scientific Review, National Date: April 16–17, 2018. Date/Time/Type: March 26, 2018,
Institute of Child Health and Human Time: 8:00 a.m. to 5:00 p.m. 2:00 p.m.–3:00 p.m. EDT, Closed.
Development, National Institutes of Health, Agenda: To review and evaluate grant Place: SAMHSA, 5600 Fishers Lane,
6710B Rockledge Drive, Bethesda, MD 20892, applications. Rockville, Maryland 20857.
(301) 435–6680, skandasa@mail.nih.gov. Place: Residence Inn Bethesda, 7335 Contact: Tracy Goss, Designated
Wisconsin Avenue, Bethesda, MD 20814.
Name of Committee: National Institute of
Contact Person: Dennis E. Leszczynski,
Federal Officer, CSAT National
Child Health and Human Development Advisory Council, 5600 Fishers Lane,
Ph.D., Scientific Review Administrator,
Special Emphasis Panel. Rockville, Maryland 20857 (mail),
Division of Scientific Review, National
Date: April 9, 2018. Telephone: (240) 276–0759, Fax: (240)
Institute of Child Health and Human
Time: 8:00 a.m. to 5:00 p.m.
Development, NIH, 6710B Rockledge Drive, 276–2252, Email: tracy.goss@
Agenda: To review and evaluate grant
applications. Bethesda, MD 20892, (301) 435–6884, samhsa.hhs.gov.
Place: Residence Inn Bethesda Downtown, leszczyd@mail.nih.gov.
Carlos Castillo,
7335 Wisconsin Ave, Bethesda, MD 20814. (Research for Mothers and Children; 93.929,
Center for Medical Rehabilitation Research; Committee Management Officer, SAMHSA.
Contact Person: Kimberly Lynette Houston,
MD, Scientific Review Officer, Division of 93.209, Contraception and Infertility Loan [FR Doc. 2018–04975 Filed 3–12–18; 8:45 am]
Scientific Review, OD, Eunice Kennedy Repayment Program, National Institutes of BILLING CODE 4162–20–P
Shriver National Institute of Child Health Health, HHS)
and Human Development, NIH, DHHS, Dated: March 7, 2018.
National Institutes of Health, 6710B DEPARTMENT OF HOMELAND
Rockledge Drive, Bethesda, MD 20892, Michelle Trout,
Program Analyst, Office of Federal Advisory SECURITY
301.827.4902, kimberly.houston@nih.gov.
Name of Committee: National Institute of Committee Policy.
Federal Emergency Management
Child Health and Human Development [FR Doc. 2018–04961 Filed 3–12–18; 8:45 am]
Agency
Special Emphasis Panel. BILLING CODE 4140–01–P
Date: April 10, 2018. [Docket ID: FEMA–2018–0018; OMB No.
Time: 8:00 a.m. to 5:00 p.m. 1660–0131]
Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
applications. HUMAN SERVICES Agency Information Collection
Place: Residence Inn Bethesda Downtown, Activities: Proposed Collection;
7335 Wisconsin Ave, Bethesda, MD 20814. Substance Abuse and Mental Health Comment Request; Threat and Hazard
Contact Person: Kimberly Lynette Houston, Identification and Risk Assessment
MD, Scientific Review Officer, Division of
Services Administration
(THIRA)—Stakeholder Preparedness
Scientific Review, OD, Eunice Kennedy
Shriver National Institute of Child Health Center for Substance Abuse Review (SPR) Reporting Tool
and Human Development, NIH, DHHS, Treatment; Notice of Meeting
AGENCY: Federal Emergency
National Institutes of Health, 6710B Management Agency, DHS.
Rockledge Drive, Bethesda, MD 20892, Pursuant to Public Law 92–463,
301.827.4902, kimberly.houston@nih.gov. notice is hereby given that the ACTION: Notice and request for
Name of Committee: National Institute of Substance Abuse and Mental Health comments.
Child Health and Human Development Services Administration’s (SAMHSA’s) SUMMARY: The Federal Emergency
Special Emphasis Panel. Center for Substance Abuse Treatment Management Agency (FEMA), as part of
Date: April 10, 2018. (CSAT) National Advisory Council will
Time: 1:00 p.m. to 4:00 p.m. its continuing effort to reduce
meet on March 26, 2018, 2:00 p.m.–3:00 paperwork and respondent burden,
Agenda: To review and evaluate contract p.m. (EDT) in a closed teleconference
proposals. invites the general public to take this
Place: National Institutes of Health, 6710B meeting. opportunity to comment on a revision of
Rockledge Drive, Bethesda, MD 20892 The meeting will include discussions a currently approved information
(Telephone Conference Call). and evaluations of grant applications collection. In accordance with the
Contact Person: Sathasiva B. Kandasamy, reviewed by SAMHSA’s Initial Review Paperwork Reduction Act of 1995, this
Ph.D., Scientific Review Administrator, Groups, and involve an examination of notice seeks comments concerning this
Division of Scientific Review, National
amozie on DSK30RV082PROD with NOTICES

Institute of Child Health and Human
confidential financial and business annual requirement for the U.S.
Development, 6710B Rockledge Drive, information as well as personal Department of Homeland Security
Bethesda, MD 20892, (301) 435–6680, information concerning the applicants. (DHS), FEMA to identify current
skandasa@mail.nih.gov. Therefore, the meeting will be closed to capability levels for all States,
Name of Committee: National Institute of the public as determined by the Territories, urban areas, and Tribes
Child Health and Human Development SAMHSA Assistant Secretary for Mental receiving non-disaster preparedness
Special Emphasis Panel. Health and Substance Use in accordance grant funds administered by DHS.

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Document Created: 2018-03-13 01:56:56
Document Modified: 2018-03-13 01:56:56

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		April 4, 2018.
FR Citation		83 FR 10863

83 FR 10863 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 49 (March 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health