Statement of Organization, Functions and Delegations of Authority, 18299-18300 [2014-07177]
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Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—ESTABLISHMENT FEE 1
Number of
responses
per respondent
Number of
respondents
Type of reporting
Average
burden
per response
Total annual
responses
Total hours
Payment of annual establishment fee .................................
Request for Small Business Establishment Fee Reduction
(Form FDA 3908) .............................................................
20
1
20
0.5
10
10
1
10
25
250
Total ..............................................................................
........................
........................
........................
........................
260
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—REINSPECTION FEE AND DISPUTE RESOLUTION REQUESTS 1
Number of
responses
per
respondent
Number of
respondents
Type of reporting
Total annual
responses
Average burden
per response
Total hours
Payment of re-inspection fee ...........................................
Reconsideration request ..................................................
Appeal request .................................................................
5
2
1
1
1
1
5
2
1
0.5
1
1
2.5
2
1
Total ..........................................................................
........................
........................
........................
..........................
5.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of recordkeeping
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
Copy of small business designation letter ...................................
10
1
10
0.5
5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding the
guidance to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
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IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
PharmacyCompounding/
ucm166743.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
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Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06884 Filed 3–31–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at Vol. 79, FR 1882
dated January 10, 2014).
This notice reflects organizational
changes to the Health Resources and
Services Administration. Specifically,
this notice updates the functional
statement for the Healthcare Systems
Bureau (RR), Office of Pharmacy Affairs
(RR7).
PO 00000
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Chapter RR—Healthcare Systems
Bureau
Section RR–20, Functions
(1) Delete the functional statement for
the Office of Pharmacy Affairs (RR7)
and replace in its entirety.
Office of Pharmacy Affairs (RR7)
The Office of Pharmacy Affairs
promotes access to clinical and cost
effective pharmacy services to enable
participating entities to stretch scarce
federal resources in order to serve more
patients, expand their services, or offer
additional services. Specifically, the
office: (1) Manages the 340B
involvement of pharmaceutical
manufacturers that participate in the
Medicaid program, through
Pharmaceutical Pricing Agreements; (2)
maintains a publicly accessible database
of participating covered entities, sites,
and contract pharmacies; (3) publishes
guidelines/regulations to assist in the
understanding and participation in the
340B Program; (4) maintains a Prime
Vendor Program to increase the value of
the 340B Program; (5) provides
technical assistance to Program
stakeholders to support their
appropriate and best use of the 340B
Program; (6) fosters mutually productive
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01APN1
18300
Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Notices
relationships with federal and private
sector partners; (7) provides a national
platform for the coordination and
development of leading practices for
pharmacy services; (8) promotes
comprehensive and efficient pharmacy
management application and systems
use to ensure safe and effective
medication use; (9) manages quality
improvement activities; and (10)
promotes program integrity compliance
and improvement activities.
Section RR–30, Delegations of
Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
Dated: March 20, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–07177 Filed 3–31–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Special Volunteer and Guest
Researcher Assignment, Office of the
Director (OD)
In compliance with the
requirement of Section 3506(c) (2) (A) of
SUMMARY:
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of Intramural Research (OIR),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Mr. Larry Chloupek,
Management Liaison Director, OIR,
Office of the Director, NIH, 2 Center
Drive MSC 0235, Bethesda, MD 20892–
0235; or call non-toll-free number 301–
594–3992; or email your request,
including your address, to
larry.chloupek@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Special
Volunteer and Guest Researcher
Assignment, 0925–0177—
EXTENSION—Office of Intramural
Research (OIR), National Institutes of
Health (NIH).
Need and Use of Information
Collection: Form Number NIH–590 is a
single form completed by an NIH
official for each Guest Researcher or
Special Volunteer prior to his/her
arrival at the NIH. The information on
the form is necessary for the approving
official to reach a decision on whether
to allow a Guest Researcher to use NIH
facilities or whether to accept volunteer
services offered by a Special Volunteer.
If the original assignment is extended,
another form notating the extension is
completed to update the file.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours is
166.
DATES:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Special Volunteers ...........................................................................................
Guest Researchers ..........................................................................................
Dated: March 25, 2014.
Lawrence A. Tabak,
Deputy Director, NIH, Office of the Director.
[FR Doc. 2014–07263 Filed 3–31–14; 8:45 am]
National Institutes of Health
National Eye Institute; Notice of
Meeting
BILLING CODE 4140–01–P
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1,250
410
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Eye Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
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Average
time per
response
Frequency
of response
1
1
6/60
6/60
Annual hour
burden
125
41
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
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]]>Agencies
[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Notices]
[Pages 18299-18300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Statement of Organization, Functions and Delegations of Authority
This notice amends Part R of the Statement of Organization,
Functions and Delegations of Authority of the Department of Health and
Human Services (HHS), Health Resources and Services Administration
(HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at
Vol. 79, FR 1882 dated January 10, 2014).
This notice reflects organizational changes to the Health Resources
and Services Administration. Specifically, this notice updates the
functional statement for the Healthcare Systems Bureau (RR), Office of
Pharmacy Affairs (RR7).
Chapter RR--Healthcare Systems Bureau
Section RR-20, Functions
(1) Delete the functional statement for the Office of Pharmacy
Affairs (RR7) and replace in its entirety.
Office of Pharmacy Affairs (RR7)
The Office of Pharmacy Affairs promotes access to clinical and cost
effective pharmacy services to enable participating entities to stretch
scarce federal resources in order to serve more patients, expand their
services, or offer additional services. Specifically, the office: (1)
Manages the 340B involvement of pharmaceutical manufacturers that
participate in the Medicaid program, through Pharmaceutical Pricing
Agreements; (2) maintains a publicly accessible database of
participating covered entities, sites, and contract pharmacies; (3)
publishes guidelines/regulations to assist in the understanding and
participation in the 340B Program; (4) maintains a Prime Vendor Program
to increase the value of the 340B Program; (5) provides technical
assistance to Program stakeholders to support their appropriate and
best use of the 340B Program; (6) fosters mutually productive
[[Page 18300]]
relationships with federal and private sector partners; (7) provides a
national platform for the coordination and development of leading
practices for pharmacy services; (8) promotes comprehensive and
efficient pharmacy management application and systems use to ensure
safe and effective medication use; (9) manages quality improvement
activities; and (10) promotes program integrity compliance and
improvement activities.
Section RR-30, Delegations of Authority
All delegations of authority and re-delegations of authority made
to HRSA officials that were in effect immediately prior to this
reorganization, and that are consistent with this reorganization, shall
continue in effect pending further re-delegation.
This reorganization is effective upon date of signature.
Dated: March 20, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014-07177 Filed 3-31-14; 8:45 am]
BILLING CODE 4165-15-P
