Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 12068-12069 [2013-03912]
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Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Device Good Manufacturing Practice
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(Agency or FDA). The meeting will be
open to the public.
Name of Committee: Device Good
Manufacturing Practice Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 11, 2013, from 8 a.m. to
6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, C and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg 66, rm.
1544, Silver Spring, MD 20993–0002,
301–796–5290,
Natasha.Facey@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On April 11, 2013, the
committee will discuss the potential
effects of extreme weather and natural
disasters on medical device
manufacturing chain processes and
marketed medical device safety and
quality. The committee will further
discuss how to optimize the use of
FDA’s current regulatory framework to
address risks and vulnerabilities to the
manufacturing chain resulting from
extreme weather conditions. Future
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steps may be identified to help industry
mitigate or better tolerate challenges to
the manufacturing chain as a result of
extreme weather conditions. In a
separate Federal Register notice, FDA is
seeking additional broad public input
about the effects of extreme weather on
medical device safety and quality.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 4, 2013. Oral
presentations from the public will be
scheduled between approximately 11
a.m. and 12 p.m. Oral presentations
from industry, professional
organizations, and societies that have an
interest in this topic will be scheduled
between approximately 1 p.m. and 2
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 27, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 29, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Committee Management Staff,
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at AnnMarie.Williams@fda.hhs.gov or
301–796–5966, at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 14, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–03963 Filed 2–20–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
Comments submitted during the first
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
Information Collection Request Title:
Drug Pricing Program Reporting
Requirements (OMB No. 0915–0176)—
[Extension].
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted section 340B of the
Public Health Service Act (PHS Act),
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
SUMMARY:
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Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula. Covered
entities which choose to participate in
the section 340B drug discount program
must comply with the requirements of
340B(a)(5) of the PHS Act. Section
340B(a)(5)(A) prohibits a covered entity
from accepting a discount for a drug that
would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits
a covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
In response to the statutory mandate
of section 340B(a)(5)(C) to develop audit
guidelines and because of the potential
for disputes involving covered entities
and participating drug manufacturers,
the HRSA Office of Pharmacy Affairs
(OPA) developed a dispute resolution
process for manufacturers and covered
entities as well as manufacturer
guidelines for audit of covered entities.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
Number of
respondents
Reporting/Notification requirement
Responses
per
respondent
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
The annual estimate of burden is as
follows:
Total
responses
Hours/
response
Total burden
hours
AUDITS
Good Faith Resolution1 .......................................................
Audit Notification of Entity 1 .................................................
Audit Workplan 1 ..................................................................
Audit Report 1 .......................................................................
Entity Response ...................................................................
10
10
8
6
6
1
1
1
1
1
10
10
8
6
6
40
4
10
10
8
400
40
80
60
48
DISPUTE RESOLUTION
Mediation Request ...............................................................
Rebuttal ................................................................................
10
10
4
1
40
10
10
16
400
160
TOTAL ..........................................................................
50
........................
80
........................
1188
Recordkeeping requirement
Number of
recordkeepers
Hours of
recordkeeping
Total burden
Dispute Records ..........................................................................................................................
50
0.5
25
1
Prepared by the manufacturer.
Recordkeeping Burden:
Submit your comments to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
Dated: February 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–03912 Filed 2–20–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
would constitute a clearly unwarranted
invasion of personal privacy.
National Institutes of Health
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Demographic/
Behavioral Population Science.
Date: March 12, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Lombardy, 2019 Pennsylvania
Avenue NW., Washington, DC 20006.
Contact Person: Marita R. Hopmann, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6911, hopmannm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, 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)
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
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]]>Agencies
[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12068-12069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
Information Collection Request Title: Drug Pricing Program
Reporting Requirements (OMB No. 0915-0176)--[Extension].
Abstract: Section 602 of Public Law 102-585, the Veterans Health
Care Act of 1992, enacted section 340B of the Public Health Service Act
(PHS Act), ``Limitation on Prices of Drugs Purchased by Covered
Entities.'' Section 340B provides that a manufacturer who sells covered
outpatient drugs to eligible entities must sign a pharmaceutical
pricing agreement with the Secretary of Health and Human Services in
which
[[Page 12069]]
the manufacturer agrees to charge a price for covered outpatient drugs
that will not exceed an amount determined under a statutory formula.
Covered entities which choose to participate in the section 340B drug
discount program must comply with the requirements of 340B(a)(5) of the
PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from
accepting a discount for a drug that would also generate a Medicaid
rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from
reselling or otherwise transferring a discounted drug to a person who
is not a patient of the entity.
In response to the statutory mandate of section 340B(a)(5)(C) to
develop audit guidelines and because of the potential for disputes
involving covered entities and participating drug manufacturers, the
HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution
process for manufacturers and covered entities as well as manufacturer
guidelines for audit of covered entities.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Reporting/Notification Number of Responses per Total Hours/ Total burden
requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
AUDITS
----------------------------------------------------------------------------------------------------------------
Good Faith Resolution\1\........ 10 1 10 40 400
Audit Notification of Entity \1\ 10 1 10 4 40
Audit Workplan \1\.............. 8 1 8 10 80
Audit Report \1\................ 6 1 6 10 60
Entity Response................. 6 1 6 8 48
----------------------------------------------------------------------------------------------------------------
DISPUTE RESOLUTION
----------------------------------------------------------------------------------------------------------------
Mediation Request............... 10 4 40 10 400
Rebuttal........................ 10 1 10 16 160
----------------------------------------------------------------------------------------------------------------
TOTAL....................... 50 .............. 80 .............. 1188
----------------------------------------------------------------------------------------------------------------
\1\ Prepared by the manufacturer.
Recordkeeping Burden:
----------------------------------------------------------------------------------------------------------------
Number of Hours of
Recordkeeping requirement recordkeepers recordkeeping Total burden
----------------------------------------------------------------------------------------------------------------
Dispute Records.............................................. 50 0.5 25
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
Deadline: Comments on this ICR should be received within 30 days of
this notice.
Dated: February 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-03912 Filed 2-20-13; 8:45 am]
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