60-day FRN 0990-0221 published

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Federal Register / Vol. 84, No. 162 / Wednesday, August 21, 2019 / Notices
• § 208.24(e) (21 CFR 208.24(e))—
Each authorized dispenser of a
prescription drug product for which a
Medication Guide is required must
provide a Medication Guide directly to
each patient when dispensing the
product to the patient or to the patient’s
agent, unless an exemption applies
under § 208.26 (21 CFR 208.26).

• § 208.26(a)—Requests may be
submitted for an exemption or a deferral
from particular Medication Guide
content or format requirements.
In the Federal Register of October 26,
2018 (83 FR 54110), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
encouraging the use of ‘‘provider-

neutral language’’ in places where terms
such as ‘‘doctor’’ or ‘‘physician’’ are
used suggesting that these terms may
cause some confusion for patients. We
are appreciative of this
recommendation; however, we decline
to implement such changes.
We estimate the burden of this
collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents

21 CFR section

Number of
responses per
respondent

Average
burden per
response

Total annual
responses

Total hours

Content and Format of a Medication Guide—§ 208.20 .......
Supplements and Other Changes to an Approved Application—§§ 314.70(b)(3)(ii) and 601.12(f) .............................
Exemptions and Deferrals—§ 208.26(a) ..............................

61

1

61

320

19,520

155
1

1
1

155
1

72
4

11,160
4

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

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

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

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

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

30,684

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Total annual
disclosures

Average burden
per disclosure

Total hours

Distributing Medication Guide to Authorized Dispenser—§ 208.24(c) .............................................
Distributing and Dispensing a Medication Guide to
Patient—§ 208.24(e) .............................................

191

9,000

1,719,000

1.25

2,148,750

88,736

5,705

506,238,880

0.05 (3 minutes)

25,311,944

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

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

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

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

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

27,460,694

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated annual reporting
burden for the information collection
reflects an overall increase of 4,664 total
hours. We attribute this adjustment to
an increase in the number of
submissions we received over the last
few years. Based on a review of the
information collection since our last
request for OMB approval, we have
made no adjustments to our annual
third-party disclosure burden estimate.
Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18000 Filed 8–20–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jspears on DSK3GMQ082PROD with NOTICES

Number of
disclosures
per
respondent

Number of
respondents

21 CFR section

[Document Identifier: OS–0990–0221]

Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

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In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before October 21, 2019.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D,
and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, [email protected], or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
SUMMARY:

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of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Family
Planning Annual Report (FPAR).
Type of Collection: Renewal with
change.
OMB No.: 0990–0221.
Abstract: The Office of Population
Affairs within the Office of the Assistant
Secretary for Health is requesting an
extension on a currently approved
Family Planning Annual Report (FPAR)
data collection and reporting tool (OMB
No. 0990–0221). This annual reporting
requirement is for family planning
services delivery projects authorized
and funded by the Title X Family
Planning Program [‘‘Population
Research and Voluntary Family
Planning Programs’’ (Public Law 91–
572)], which was enacted in 1970 as
Title X of the Public Health Service Act
(Section 1001; 42 U.S.C. 300). The FPAR
data collection and reporting tool will
include a new module to collect

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Federal Register / Vol. 84, No. 162 / Wednesday, August 21, 2019 / Notices

substance use disorder (SUD) screening
data in this request to extend an OMB
approval to collect essential, annual
data from Title X grantees.
Need and Proposed Use of the
Information: The Title X Family
Planning Program (‘‘Title X program’’ or
‘‘program’’) is the only Federal grant
program dedicated solely to providing
individuals with comprehensive family
planning and related preventive health
services (e.g., screening for breast and
cervical cancer, sexually transmitted

diseases (STDs), and human
immunodeficiency virus). By law,
priority is given to persons from lowincome families (Section 1006[c] of Title
X of the Public Health Service Act, 42
U.S.C. 300). The Office of Population
Affairs (OPA) within the Office of the
Assistant Secretary for Health
administers the Title X program.
Likely Respondents: Respondents for
this annual reporting requirement are
centers that receive funding directly
from OPA for family planning services

authorized and funded under the Title
X Family.
This weighted average hour burden
accounts for differences in reporting
burden by type of grantee agency
grantee (e.g., public health department
or private agency), as found in the 2009
FPAR Burden Study. For purposes of
this estimate, the average hour burden
ranges between 39 hours (public health
department) and 32 hours (private
agency).

ANNUALIZED BURDEN HOUR TABLE
Number of
responses per
respondents

Average
annualized
burden per
response
(hours)

Annualized
total burden
(hours)

Type of respondents

Form name

Grantees ...........................................

FPAR ................................................

93

1

36

3,348

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

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

93

1

36

3,348

Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, 240–498–
7546, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)

Terry Clark,
Asst. Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
[FR Doc. 2019–18046 Filed 8–20–19; 8:45 am]
BILLING CODE 4150–34–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.

jspears on DSK3GMQ082PROD with NOTICES

Number of
respondents

Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Respiratory Sciences.
Date: September 13, 2019.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ghenima Dirami, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of

VerDate Sep<11>2014

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Jkt 247001

Dated: August 15, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17989 Filed 8–20–19; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute Of General Medical
Sciences; 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
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
General Medical Sciences Special Emphasis

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Panel; Review of NIGMS Support of
Competitive Research (SCORE) Award
Applications.
Date: October 11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Brian R. Pike, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892 301–594–3907, [email protected].
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of NIGMS Support of
Competitive Research (SCORE) Award
Applications.
Date: November 1, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Manas Chattopadhyay,
Ph.D., Scientific Review Officer, Office of
Scientific Review, National Institute of
General Medical Sciences, National Institutes
of Health, 45 Center Drive, Room 3AN12,
Bethesda, MD 20892, 301–827–5320,
[email protected].
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of NIGMS Support of
Competitive Research (SCORE) Award
Applications.
Date: November 20, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Nina Sidorova, Ph.D.,
Scientific Review Officer, Office of Scientific

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