Notice of Availability of Draft Policy Document for Comment, 56364-56365 [E7-19507]
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Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices
both the pilot project and the draft
SEND implementation guide can be
found on the FDA SEND Web page at
https://www.fda.gov/oc/datacouncil/
send.html. Before creating and
submitting nonclinical datasets, pilot
participants should ensure that they use
the most recent draft version of the
SEND implementation guide.
II. Pilot Project Description
This pilot project is part of an ongoing
effort to improve the efficiency of the
review of nonclinical data within CDER.
Eventually, as experience from the
ongoing pilot is gained with various
types of nonclinical studies, CDER
expects to recommend new technical
specifications as part of a continuing
process for the submission of
nonclinical study data provided
electronically and eliminate the need to
provide paper/PDF-based data listing.
rwilkins on PROD1PC63 with NOTICES
A. Approach
CDER is seeking a limited number of
sponsors (i.e., approximately five to
eight) to participate in the phase 2 pilot.
The duration of the pilot is expected to
be approximately 3 years, but it may be
extended as needed. Participants should
be familiar with SEND (e.g., from
involvement in the phase 1 pilot) and be
willing to provide the same nonclinical
study data in both PDF and SEND
formats to an existing IND. The PDF
must comply with all applicable
regulations, including those in part 11
(21 CFR part 11)1. To achieve the goals
of the pilot, FDA intends to exercise
additional enforcement discretion with
regard to part 11 requirements as
applied to data submitted in SEND
format under this pilot. That is, we do
not intend to take enforcement action
against data submitted in SEND format,
under this pilot, to enforce compliance
with those portions of part 11 that
remain in effect. The SAS transport files
(version 5) should be based on the
SEND format. Having the same data
available in both PDF and SEND formats
provides the best opportunity to
compare the two and evaluate the
accuracy and reliability of the SEND
format. Although the PDF version will
continue to be the version used for
archival purposes during the pilot, both
data formats (i.e., PDF and SEND) will
be used by FDA for regulatory review
purposes. Before receiving any SEND
data, FDA and pilot participants will
work with the SEND Consortium to
update the SEND implementation guide,
1 See, ‘‘Guidance for Industry; Part 11, Electronic
Records; Electronic Signatures—Scope and
Application,’’ August, 2003; https://www.fda.gov/
Cder/guidance/5667fnl.htm
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18:31 Oct 02, 2007
Jkt 211001
which will then be used during the
pilot.
For the purposes of this phase 2 pilot,
full study reports of the following types
of animal toxicity studies will be
requested for submission to an existing
IND in the appropriate CDER review
division: (1) Repeat-dose toxicity
studies of 14 days duration to 12
months duration in any species, (2) lifetime carcinogenicity studies in rats or
mice, or (3) 6-month carcinogenicity
studies in transgenic mice. Studies
should include toxicokinetic data, if
available. For submission of
carcinogenicity studies, the appropriate
CDER and International Conference on
Harmonization (ICH) guidances should
be consulted. The submission should
contain both the ‘‘Tumor Dataset for
Statistical Analysis’’ (i.e., tumor.xpt, as
described in Appendix 1 of the Study
Data Specifications document; version
1.3; dated 2006–11–27) as well as the
SEND-formatted datasets for the entire
study. Depending on the ongoing efforts
of the SEND Consortium to expand the
SEND implementation guide, additional
nonclinical study types may be piloted
in the future. If so, FDA will post on the
FDA SEND Web page an updated list of
study types the agency will accept in
this and any future pilots. We anticipate
that a successful phase 2 pilot, which
includes implementation of any needed
changes to the SEND implementation
guide and/or the data validation,
viewing, and analysis tools, will allow
CDER to routinely accept specific types
of nonclinical study data provided
electronically as SAS transport file (XPT
version 5) datasets based on the SEND
format. In the case of carcinogenicity
studies, a successful phase 2 pilot will
enable submission of the entire
carcinogenicity study data in the
electronic SEND format, thus
eliminating the need for a separate
submission of the electronic tumor
dataset (i.e., tumor.xpt).
B. How to Participate
Requests to participate in the pilot
project should be submitted to the
Division of Dockets Management (see
ADDRESSES). Requests are to be
identified with the docket number
found in brackets in the heading of this
document. As mentioned above, it is
recommended that interested
participants be familiar with SEND and/
or have been involved in the previous
phase 1 pilot.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this pilot project.
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Fmt 4703
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Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
Dated: September 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–19468 Filed 10–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Draft Policy
Document for Comment
Health Resources and Services
Administration (HRSA), HHS.
ACTION: This is a Notice of Availability
and request for comments on a draft
Agency Guidance (‘‘Policy Information
Notice’’ (PIN)) to clarify program and
application requirements of the
Federally Qualified Health Center LookAlike program and make them
consistent with those requirements
under section 330 of the Public Health
Service Act. The PIN, ‘‘Federally
Qualified Health Center (FQHC) LookAlike Guidelines and Application’’
(‘‘FQHC Look-Alike PIN’’) is available
on the Internet at https://bphc.hrsa.gov/
draftsforcomment/lookalike/.
AGENCY:
Comments must be received by
close of business November 7, 2007.
ADDRESSES: Please send your comments
to the following e-mail address:
DPDgeneral@hrsa.gov.
SUMMARY: HRSA believes that
community input is valuable to the
development of policies and policy
documents related to the
implementation of BPHC programs,
including the FQHC Look-Alike
Program. Therefore, we are requesting
comments on the PIN referenced above.
After review and consideration of all
comments received, the PIN may be
amended to incorporate certain
recommendations from the public. Once
the PIN is finalized, it will be made
available on HRSA’s Web site, along
with the Agency’s ‘‘Response to Public
Comments.’’ That document will
summarize the major comments
received and describe the Agency’s
response, including any corresponding
DATES:
E:\FR\FM\03OCN1.SGM
03OCN1
rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices
changes made to the PIN. Where
comments do not result in a revision to
the PIN, explanations will be provided.
Background: HRSA has received
numerous requests for clarification
regarding the program guidelines,
requirements, and application process
for the FQHC Look-Alike program. The
purpose of the FQHC Look-Alike PIN is
to respond to these requests for
clarification and to make the application
process more consistent with section
330 grant programs.
The Omnibus Budget Reconciliation
Acts of 1989, 1990, and 1993 amended
section 1905 of the Social Security Act
to create a new category of facility under
Medicaid and Medicare known as
Federally Qualified Health Centers
(FQHCs). The Social Security Act
§ 1905(l)(2)(B) definition of an FQHC
included an entity which, based on the
recommendation of HRSA, is
determined to meet the requirements of
the section 330 grant program but does
not receive the grant. This category of
health centers has been labeled FQHC
Look-Alikes.
To ensure that there are appropriate
numbers of health centers to serve the
millions of uninsured and underinsured
populations throughout the country,
FQHC Look-Alike status was made
available to those entities that do not
receive funding under section 330 but
operate and provide services similar to
grant-funded programs. As such, FQHC
Look-Alikes are expected to
demonstrate a commitment to serve all
populations residing in their respective
medically underserved communities
regardless of their ability to pay and to
satisfy all of the administrative,
management, governance and servicerelated requirements that apply to
section 330 funded health centers.
Benefits of obtaining FQHC Look-Alike
status include eligibility for enhanced
Medicaid and Medicare reimbursement,
participation in the 340(b) Federal Drug
Pricing Program, and automatic Health
Professional Shortage Area designation.
HRSA is responsible for managing the
FQHC Look-Alike program and
submitting recommendations to the
Centers for Medicare and Medicaid
Services (CMS) for designation as
FQHCs; however, CMS has the final
authority to designate applicants as
FQHCs. The organizations are
recertified annually to assure they are in
compliance with these regulations.
For
questions regarding this notice, please
contact Cicely Nelson at (301) 594–
4496.
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
18:31 Oct 02, 2007
Jkt 211001
Dated: September 24, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–19507 Filed 10–2–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Director’s Council of Public
Representatives.
The meeting will be open to the
public, with attendance limited to space
available. 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.
Name of Committee: Director’s Council of
Public Representatives.
Date: October 26, 2007.
Time: 8:30 a.m. to adjournment.
Agenda: Key topics for this meeting will
focus on public engagement in the
biomedical and behavioral research process.
Further information will be available on the
COPR Web site in mid-October at
www.copr.nih.gov.
Place: National Institutes of Health,
Building 31, Conference Room 6, 9000
Rockville Pike, Bethesda, MD 20892.
Contact Person: Kelli L. Carrington,
Executive Secretary/Public Liaison Officer,
Office of Communications and Public
Liaison, Office of the Director, National
Institutes of Health, 9000 Rockville Pike,
Building 1, Room 344, Bethesda, MD 20892,
301–594–4575, carringk@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.copr.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
PO 00000
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56365
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: September 26, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–4864 Filed 10–2–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Cancer Institute Clinical Trials
Advisory Committee.
The meeting will be open to the
public, with attendance limited to space
available. 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.
Name of Committee: National Cancer
Institute Clinical Trials Advisory Committee.
Date: November 14, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: Update on the progress of the
implementation of the Clinical Trials
Working Group.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Room 10,
Bethesda, MD 20892.
Contact Person: Sheila A. Prindiville, MD,
Director, Coordinating Center for Clinical
Trials, Office of the Director, National Cancer
Institute, National Institutes of Health, 6120
Executive Blvd., Suite 507, Bethesda, MD
20892, 301–451–5048,
prindivs@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 72, Number 191 (Wednesday, October 3, 2007)]
[Notices]
[Pages 56364-56365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Availability of Draft Policy Document for Comment
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: This is a Notice of Availability and request for comments on a
draft Agency Guidance (``Policy Information Notice'' (PIN)) to clarify
program and application requirements of the Federally Qualified Health
Center Look-Alike program and make them consistent with those
requirements under section 330 of the Public Health Service Act. The
PIN, ``Federally Qualified Health Center (FQHC) Look-Alike Guidelines
and Application'' (``FQHC Look-Alike PIN'') is available on the
Internet at https://bphc.hrsa.gov/draftsforcomment/lookalike/.
-----------------------------------------------------------------------
DATES: Comments must be received by close of business November 7, 2007.
ADDRESSES: Please send your comments to the following e-mail address:
DPDgeneral@hrsa.gov.
SUMMARY: HRSA believes that community input is valuable to the
development of policies and policy documents related to the
implementation of BPHC programs, including the FQHC Look-Alike Program.
Therefore, we are requesting comments on the PIN referenced above.
After review and consideration of all comments received, the PIN may be
amended to incorporate certain recommendations from the public. Once
the PIN is finalized, it will be made available on HRSA's Web site,
along with the Agency's ``Response to Public Comments.'' That document
will summarize the major comments received and describe the Agency's
response, including any corresponding
[[Page 56365]]
changes made to the PIN. Where comments do not result in a revision to
the PIN, explanations will be provided.
Background: HRSA has received numerous requests for clarification
regarding the program guidelines, requirements, and application process
for the FQHC Look-Alike program. The purpose of the FQHC Look-Alike PIN
is to respond to these requests for clarification and to make the
application process more consistent with section 330 grant programs.
The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1993
amended section 1905 of the Social Security Act to create a new
category of facility under Medicaid and Medicare known as Federally
Qualified Health Centers (FQHCs). The Social Security Act Sec.
1905(l)(2)(B) definition of an FQHC included an entity which, based on
the recommendation of HRSA, is determined to meet the requirements of
the section 330 grant program but does not receive the grant. This
category of health centers has been labeled FQHC Look-Alikes.
To ensure that there are appropriate numbers of health centers to
serve the millions of uninsured and underinsured populations throughout
the country, FQHC Look-Alike status was made available to those
entities that do not receive funding under section 330 but operate and
provide services similar to grant-funded programs. As such, FQHC Look-
Alikes are expected to demonstrate a commitment to serve all
populations residing in their respective medically underserved
communities regardless of their ability to pay and to satisfy all of
the administrative, management, governance and service-related
requirements that apply to section 330 funded health centers. Benefits
of obtaining FQHC Look-Alike status include eligibility for enhanced
Medicaid and Medicare reimbursement, participation in the 340(b)
Federal Drug Pricing Program, and automatic Health Professional
Shortage Area designation.
HRSA is responsible for managing the FQHC Look-Alike program and
submitting recommendations to the Centers for Medicare and Medicaid
Services (CMS) for designation as FQHCs; however, CMS has the final
authority to designate applicants as FQHCs. The organizations are
recertified annually to assure they are in compliance with these
regulations.
FOR FURTHER INFORMATION CONTACT: For questions regarding this notice,
please contact Cicely Nelson at (301) 594-4496.
Dated: September 24, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-19507 Filed 10-2-07; 8:45 am]
BILLING CODE 4165-15-P
