Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representative on the Pediatric Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on the Pediatric Advisory Committee, 47853-47854 [2012-19639]
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Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
metastases in beneficiaries in whom
bone metastases are strongly suspected
based on clinical symptoms or the
results of other diagnostic studies.
Qualifying clinical studies must ensure
that specific hypotheses are addressed;
appropriate data elements are collected;
hospitals and providers are qualified to
provide the PET scan and interpret the
results; participating hospitals and
providers accurately report data on all
Medicare enrolled patients; and all
patient confidentiality, privacy, and
other Federal laws must be followed.
Consistent with section 1142 of the
Social Security Act, the Agency for
Healthcare Research and Quality
(AHRQ) supports clinical research
studies that the CMS determines meet
specified standards and address the
specified research questions. To qualify
for payment, providers must prescribe
certain NaF–18 PET scans for
beneficiaries with a set of clinical
criteria specific to each solid tumor. The
statuary authority for this policy is
section 1862 (a)(1)(E) of the Social
Security Act. The need to prospectively
collect information at the time of the
scan is to assist the provider in decision
making for patient management. Form
Number: CMS–10152 (OCN: 0938–
0968); Frequency: Annual; Affected
Public: Private Sector—Business or
other for-profits; Number of
Respondents: 25,000; Total Annual
Responses: 25,000; Total Annual Hours:
2,084. (For policy questions regarding
this collection contact Stuart Caplan at
410–786–8564. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Reinstatement of a currently
approved collection; Title: Medicare
Program: Procedures for Making
National Coverage Decisions; Use: The
Centers for Medicare & Medicaid
Services (CMS) revised the April 27,
1999 (64 FR 22619) notice and
published a new notice on September
26, 2003 (68 FR 55634) that described
the process we use to make Medicare
coverage decisions including decisions
regarding whether new technology and
services can be covered. We have made
changes to our internal procedures in
response to the comments we received
following publication of the 1999 notice
and experience under our new process.
Over the past several years, we received
numerous suggestions to further revise
our process to continue to make it more
open, responsive, and understandable to
the public. We share the goal of
increasing public participation in the
development of Medicare coverage
issues. This will assist us in obtaining
the information we require to make a
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national coverage determination in a
timely manner and ensuring that the
Medicare program continues to meet the
needs of its beneficiaries. Form Number:
CMS–R–290 (OCN: 0938–0776);
Frequency: Annual; Affected Public:
Private Sector: Business or other forprofits; Number of Respondents: 200;
Total Annual Responses: 200; Total
Annual Hours: 8,000. (For policy
questions regarding this collection
contact Katherine Tillman at 410–786–
9252. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by October 9, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: August 7, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–19694 Filed 8–9–12; 8:45 am]
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PO 00000
47853
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0781]
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representative on
the Pediatric Advisory Committee and
Request for Nominations for
Nonvoting Industry Representatives on
the Pediatric Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Pediatric Advisory
Committee for the Office of the
Commissioner (OC) notify FDA in
writing. FDA is also requesting
nominations for a nonvoting industry
representative(s) to serve on the
Pediatric Advisory Committee. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nominations will be
accepted for current vacancies effective
with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by September 10, 2012, for the
vacancy listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by September 10, 2012.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Walter Ellenberg (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Walter Ellenberg, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 301–796–0885, FAX: 301–
847–8640, walter.ellenberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. OC Advisory Committee
Pediatric Advisory Committee
The Committee reviews and evaluates
and makes recommendations to the
Commissioner of Food and Drugs
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47854
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
regarding: (1) Pediatric research
conducted under sections 351, 409I, and
499 of the Public Health Service Act and
sections 501, 502, 505, 505A, and 505B,
510K, 515, and 520m of the Federal
Food, Drug, and Cosmetic Act; (2)
identification of research priorities
related to pediatric therapeutics
(including drugs and biological
products) and medical devices for
pediatric populations and the need for
additional diagnostics and treatments of
specific pediatric diseases or conditions,
(3) the ethics, design, and analysis of
clinical trials related to pediatric
therapeutics (including drugs and
biological products) and medical
devices, (4) pediatric labeling disputes
as specified in Public Law 107–109 and
Public Law 110–85, (5) pediatric
labeling changes as specified in Public
Law 107–109 and Public Law 110–85,
(6) adverse event reports for drugs
studied under Public Law 107–109 and
110–85 and labeled, (7) any safety issues
that may occur as specified Public Law
107–109 and Public Law 110–85, (8) any
other pediatric issue or pediatric
labeling dispute involving FDAregulated products, (9) pediatric ethical
issues including research involving
children as subjects as specified in 21
CFR 50.54; and (10) any other matter
involving pediatrics for which FDA has
regulatory responsibility.
The Committee also advises and
makes recommendations to the
Secretary directly or to the Secretary
through the Commissioner on research
involving children as subjects that is
conducted or supported by the
Department of Health and Human
Services as specified in 45 CFR 46.407.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
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18:02 Aug 09, 2012
Jkt 226001
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the pediatric
pharmaceutical research and
biotechnology manufacturing industry.
Authority: This notice is issued under the
Federal Advisory Committee Act (5 U.S.C.
app. 2) and 21 CFR part 14, relating to
advisory committees.
Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19639 Filed 8–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Information Collection
Activity: Comment Request
The Health Resources and Services
Administration (HRSA) periodically
publishes abstracts of information
collection submitted for review to the
Office of Management and Budget
(OMB) in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
clearance requests submitted to OMB for
review, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Office
at (301) 443–1984.
The following request has been
submitted to the Office of Management
PO 00000
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and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Maternal, Infant, and
Early Childhood Home Visiting
Program Information System: Data
Collection Forms (OMB No. 0915–
xxxx)—[New]
On March 23, 2010, the President
signed into law the Patient Protection
and Affordable Care Act of 2010 (Pub.
L. 111–148), legislation designed to
make quality, affordable, health care
available to all Americans, reduce costs,
improve health care quality, enhance
disease prevention, and strengthen the
health care workforce. Through a
provision authorizing the creation of the
Maternal, Infant, and Early Childhood
Home Visiting (MIECHV) Program, the
Act responds to the diverse needs of
children and families in communities at
risk and provides an unprecedented
opportunity for collaboration and
partnership at the Federal, State, Tribal,
and community levels to improve health
and development outcomes for at-risk
children through evidence-based home
visiting programs. The MIECHV
Program is designed: (1) To strengthen
and improve the programs and activities
carried out under Title V; (2) to improve
coordination of services for at-risk
communities; and (3) to identify and
provide comprehensive services to
improve outcomes for families who
reside in at-risk communities. Formulabased and competitive grants have been
awarded to States, other eligible
jurisdictions, and, under a legislative
provision setting aside dedicated funds
for a Tribal MIECHV program, to eligible
Indian Tribes and consortia of Tribes,
Tribal Organizations, and Urban Indian
Organizations. Competitive grants to
non-profit organizations to provide
home visiting in certain States are
anticipated.
The Social Security Act, Title V,
Section 511 (42 U.S.C. 711), as amended
by the Patient Protection and Affordable
Care Act of 2010, requires that MIECHV
grantees collect both socio-demographic
data and data to measure improvements
for eligible families in six specified
areas (referred to as ‘‘benchmark areas’’)
that encompass the major goals for the
program. The Supplemental Information
Request for the Submission of the
Updated State Plan for a State Home
Visiting Program (SIR), published on
February 8, 2011, further listed a variety
of constructs under each benchmark
area for which grantees were to select
and submit relevant performance
measures. Per Section 511(d)(1)(B)(i) of
the legislation, no later than 30 days
after the end of the third year of the
program, grantees are required to
E:\FR\FM\10AUN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47853-47854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19639]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0781]
Request for Notification From Industry Organizations Interested
in Participating in Selection Process for Nonvoting Industry
Representative on the Pediatric Advisory Committee and Request for
Nominations for Nonvoting Industry Representatives on the Pediatric
Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Pediatric Advisory
Committee for the Office of the Commissioner (OC) notify FDA in
writing. FDA is also requesting nominations for a nonvoting industry
representative(s) to serve on the Pediatric Advisory Committee. A
nominee may either be self-nominated or nominated by an organization to
serve as a nonvoting industry representative. Nominations will be
accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by September
10, 2012, for the vacancy listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by September 10, 2012.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Walter Ellenberg (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Walter Ellenberg, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 301-796-0885, FAX: 301-
847-8640, walter.ellenberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. OC Advisory Committee
Pediatric Advisory Committee
The Committee reviews and evaluates and makes recommendations to
the Commissioner of Food and Drugs
[[Page 47854]]
regarding: (1) Pediatric research conducted under sections 351, 409I,
and 499 of the Public Health Service Act and sections 501, 502, 505,
505A, and 505B, 510K, 515, and 520m of the Federal Food, Drug, and
Cosmetic Act; (2) identification of research priorities related to
pediatric therapeutics (including drugs and biological products) and
medical devices for pediatric populations and the need for additional
diagnostics and treatments of specific pediatric diseases or
conditions, (3) the ethics, design, and analysis of clinical trials
related to pediatric therapeutics (including drugs and biological
products) and medical devices, (4) pediatric labeling disputes as
specified in Public Law 107-109 and Public Law 110-85, (5) pediatric
labeling changes as specified in Public Law 107-109 and Public Law 110-
85, (6) adverse event reports for drugs studied under Public Law 107-
109 and 110-85 and labeled, (7) any safety issues that may occur as
specified Public Law 107-109 and Public Law 110-85, (8) any other
pediatric issue or pediatric labeling dispute involving FDA-regulated
products, (9) pediatric ethical issues including research involving
children as subjects as specified in 21 CFR 50.54; and (10) any other
matter involving pediatrics for which FDA has regulatory
responsibility.
The Committee also advises and makes recommendations to the
Secretary directly or to the Secretary through the Commissioner on
research involving children as subjects that is conducted or supported
by the Department of Health and Human Services as specified in 45 CFR
46.407.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from the pediatric pharmaceutical research and
biotechnology manufacturing industry.
Authority: This notice is issued under the Federal Advisory
Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to
advisory committees.
Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19639 Filed 8-9-12; 8:45 am]
BILLING CODE 4160-01-P
