30-day FRN

Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
guidance is to assist sponsors in the
clinical development of fixed
combination drug products for the
treatment of hypertension. The guidance
focuses on development of two-drug
combinations of previously approved
drug products. This guidance
incorporates the comments received for
and finalizes the draft guidance for
industry entitled ‘‘Hypertension:
Developing Fixed-Dose Combination
Drugs for Treatment’’ issued on January
26, 2018 (83 FR 3735). All the public
comments received on the draft
guidance have been considered, and the
guidance was revised as appropriate
primarily for editorial changes.
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 ‘‘Hypertension:
Developing Fixed-Combination Drug
Products for Treatment.’’ 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. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 has
been approved under OMB control
number 0910–0014. The collection of
information in the guidance for industry
entitled ‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims’’ (available at https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm075072.pdf) has been
approved under OMB control number
0910–0670.

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III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24315 Filed 11–6–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute on
Aging Special Emphasis Panel,
November 19, 2018, 8:30 a.m. to
November 19, 2018, 4:00 p.m., National
Institute on Aging, Gateway Building,
7201 Wisconsin Avenue, Suite 2W200,
Bethesda, MD 20892 which was
published in the Federal Register on
October 30, 2018, 83 FR 54605.
The meeting notice is amended to
change the meeting location from the
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2W200, Bethesda, MD 20892 to
Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814. The meeting
is closed to the public.
Dated: November 1, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–24293 Filed 11–6–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: Data and Specimen
Hub (DASH) (Eunice Kennedy Shriver
National Institute of Child Health and
Human Development)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:

Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
[email protected] or by

ADDRESSES:

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fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Rohan Hazra,
M.D., Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, 6710B Rockledge
Drive, Room 2113, Bethesda, MD 20817,
or call non-toll-free number (301)–435–
6868 or Email your request, including
your address to: [email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 27, 2018, page 18576
(Vol 83) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Data and
Specimen Hub (DASH) 0925–0774 exp.
date 6/30/19—REVISION; Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection:
This is a request to revise the
previously approved submission to add
the collection of additional information
from Users who will request
biospecimens, submit the Institutional
Certification for data/biospecimen
inventory, and submit DASH data/
biospecimen Annual Progress Report for
the NICHD Data and Specimen Hub
(DASH). DASH has been established by
NICHD as a data sharing mechanism for
biomedical research investigators. It
serves as a centralized resource for
investigators to store and access
deidentified study data and
biospecimen inventories—a list of
biospecimens available at the NICHD

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Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices

Biorepository—from studies funded by
NICHD. The potential for public benefit
to be achieved through sharing study
data and/or biospecimen inventories for
secondary analysis is significant. NICHD
DASH supports NICHD’s mission to
ensure that every person is born healthy
and wanted, that women suffer no
harmful effects from reproductive
processes, and that all children have the
chance to achieve their full potential for
healthy and productive lives, free from
disease or disability, and to ensure the
health, productivity, independence, and
well-being of all people through optimal
rehabilitation. Study data and
biospecimen sharing and reuse will
promote testing of new hypotheses from
data already collected, facilitate
transdisciplinary collaboration,
accelerate scientific findings and enable
NICHD to maximize the return on its
investments in research.
Anyone can access NICHD DASH to
browse and view descriptive
information about the studies and study

data archived in NICHD DASH without
creating an account. Users who wish to
submit or request research data and/or
biospecimen inventories must register
for an account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
Users. Those submitting or requesting
data and/or biospecimen inventories
will be required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimen inventories. The
information collected is limited to the
essential data required to ensure the
management of Users in NICHD DASH
is efficient and the sharing of data and
biospecimens among investigators is
effective. The primary uses of the
information collected from Users by
NICHD will be to:
• Communicate with the Users with
regards to their data submission, data
requests and biospecimen requests

• Monitor data submissions, data
requests and biospecimen requests
• Notify interested recipients of updates
to data and biospecimen inventories
stored in NICHD DASH
• Help NICHD understand the use of
NICHD DASH study data and
biospecimen inventories by the
research community
All the data collected from use of
NICHD DASH except for information
provided in the annual progress reports
are for the purposes of internal
administrative management of NICHD
DASH. Information gathered through
the annual progress reports may be used
in publications describing performance
of the DASH system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
204.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form

Average time
per response
(in hours)

Total annual
burden hour

User Registration .............................................................................................
Data Submission and Biospecimen Inventory Submissions ...........................
Data Request ...................................................................................................
Biospecimen Request ......................................................................................
Data Use Annual Progress Report ..................................................................
Biospecimen Use Annual Progress Report .....................................................
Institutional Certification Template ..................................................................

200
36
60
36
60
36
36

1
1
1
1
1
1
1

5/60
2
1
1
10/60
10/60
5/60

17
72
60
36
10
6
3

Total ..........................................................................................................

200

200

........................

204

Dated: November 1, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
[FR Doc. 2018–24313 Filed 11–6–18; 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 Closed Meeting
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Number of
responses
per
respondent

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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Primate Center for Gene Therapy.
Date: November 30, 2018.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7180, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Tony L Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, National Institutes of Health,
6701 Rockledge Drive, Room 7180, Bethesda,
MD 20892–7924, 301–827–7913.

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(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: November 1, 2018.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–24294 Filed 11–6–18; 8:45 am]
BILLING CODE 4140–01–P

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