Agency Information Collection Request; 60-Day Public Comment Request, 43609-43610 [2019-18046]
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43609
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:
VerDate Sep<11>2014
18:13 Aug 20, 2019
Jkt 247001
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
Sherrette.Funn@hhs.gov 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, Sherrette.funn@hhs.gov, 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:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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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21AUN1
43610
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, diramig@csr.nih.gov.
(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
18:13 Aug 20, 2019
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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Fmt 4703
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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, pikebr@mail.nih.gov.
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,
manasc@mail.nih.gov.
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
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Pages 43609-43610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0221]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 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
[[Page 43610]]
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 low-income 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
----------------------------------------------------------------------------------------------------------------
Average
Number of annualized Annualized
Type of respondents Form name Number of responses per burden per total burden
respondents respondents response (hours)
(hours)
----------------------------------------------------------------------------------------------------------------
Grantees...................... FPAR............ 93 1 36 3,348
---------------------------------------------------------------
Total..................... ................ 93 1 36 3,348
----------------------------------------------------------------------------------------------------------------
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
