Food and Drug Administration Transparency Task Force; Request for Comments, 11893-11894 [2010-5377]
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11893
Federal Register / Vol. 75, No. 48 / Friday, March 12, 2010 / Notices
match the sample sizes reported by the
State.
In Appendix D (List Sampling Frame
Coverage Study), the following changes
are being made with respect to the
Annual Synar Report:
Question 2. Percent Coverage Found.
This question has been split into 4 subparts, asking the State to report the
unweighted percent coverage found, the
weighted percent coverage found, the
number of outlets found through
canvassing, and the number of outlets
matched on the list frame. The question
has been split into these sub-parts to
avoid SAMHSA/CSAP having to request
additional clarifying information from
the State during the review process.
Question 3. Description of the
Coverage Study Methods and Results.
This question has been expanded from
one question to ten questions, which ask
the State to provide specific information
about the coverage study methods and
results. Specifically, instead of one
general question asking the State to
‘‘provide a description of the coverage
study methods and results,’’ the ten new
questions query the State about specific
aspects of the coverage study design,
methodology and results. These specific
questions will reduce the need for
SAMHSA/CSAP to request additional
clarifying information from the State
during the review process.
There are no changes to Section II
(Intended Use), or to Forms 1–5 or
Appendix C.
ANNUAL REPORTING BURDEN
Number of
respondents
45 CFR citation
Responses
per
respondents
1
Hours per
response
Total hour
burden
Annual Report (Section 1—States and Territories) 96.130(e)(1–3) ................
State Plan (Section II–States and Territories) 96.130(e)(4,5)96.130(g) .........
59
59
1
1
15
3
885
177
Total ..........................................................................................................
59
........................
........................
1,062
1
Red Lake Indian Tribe is not subject to tobacco requirements.
Written comments and
recommendations concerning the
proposed information collection should
be sent by April 12, 2010 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–5806.
Dated: March 5, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–5400 Filed 3–11–10; 8:45 am]
BILLING CODE 4162–20–P
Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Afia
Asamoah, Office of the Commissioner,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, rm. 2220,
Silver Spring, MD 20993–0002, 301–
796–4625, FAX: 301–847–3531, e-mail:
Afia.Asamoah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0247]
Food and Drug Administration
Transparency Task Force; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is soliciting
comments from interested persons on
ways in which FDA can increase
transparency between FDA and
regulated industry.
DATES: Submit electronic or written
comments by April 12, 2010.
VerDate Nov<24>2008
17:18 Mar 11, 2010
Jkt 220001
Transparency promotes accountability
and provides information to the public
about government activities and
initiatives. For FDA, providing
information to the public in a timely,
user-friendly manner is important to
enhance the work of the agency.
Government transparency and
accountability is a priority for the
Obama Administration. On January 21,
2009, President Obama instructed
executive departments and agencies to
take appropriate action, consistent with
law and policy, to disclose information
to the public rapidly, and in a form that
is easily accessible and user friendly.
Executive departments and agencies
have been charged with harnessing new
technologies to make information about
agency operations and decisions
available online and readily available to
the public. Executive departments and
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
agencies have been asked to solicit
public input to identify information of
greatest use to the public.
The Open Government Directive,
issued by the Director of the Office of
Management and Budget on December
8, 2009, further instructed executive
departments and agencies to take
specific actions to implement a
transparent, collaborative, and
participatory government.
FDA has formed an internal
Transparency Task Force to develop
recommendations for making useful and
understandable information about FDA
activities and decisionmaking more
readily available to the public. The
recommendations will focus on
disclosing relevant information in a
timely manner and in a user-friendly
format, and in a manner compatible
with the agency’s goal of protecting
confidential information, as appropriate.
As a part of this transparency initiative,
the Task Force has held two public
meetings, on June 24, 2009, and
November 3, 2009, and established a
public docket to seek public input on
these issues. As a result of the input the
Task Force has received thus far, it has
decided to separate the Transparency
Initiative into three phases: (1) Creating
a Web-based resource called ‘‘FDA
Basics,’’ that provides information about
commonly misunderstood agency
activities and frequently asked
questions; (2) improving FDA’s
disclosure of information to the public;
and (3) improving FDA’s transparency
to regulated industry.
The first two phases are complete or
well underway. ‘‘FDA Basics’’ was
launched on FDA’s Web site on January
E:\FR\FM\12MRN1.SGM
12MRN1
11894
Federal Register / Vol. 75, No. 48 / Friday, March 12, 2010 / Notices
12, 2010. The two public meetings held
in 2009 and prior specific requests for
comments focused on how FDA can
improve its disclosure to the public. The
Task Force soon plans to issue draft
proposals related to those issues for
public comment. This document focuses
on the third phase of the transparency
initiative.
srobinson on DSKHWCL6B1PROD with NOTICES
II. Scope of the Meeting
The Task Force is collecting
information on how to improve FDA’s
transparency to regulated industry. It
held three listening sessions with
members of regulated industry on
January 21, 27, and 28, 2010. FDA is
making available transcripts and
summaries of those listening sessions
(see section IV of this document), and
seeks public comment related to the
issues raised in those sessions or other
suggestions related to FDA’s
transparency to regulated industry. FDA
is particularly interested in comments
on how FDA can make improvements in
the following areas:
1. Training and education for
regulated industry about the FDA
regulatory process in general and/or
about specific new requirements.
2. The guidance development process.
3. Maintaining open channels of
communication with industry routinely
and during crises.
4. Providing useful and timely
answers to industry questions about
specific regulatory issues.
5. Communicating with sponsors
during review of applications.
III. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
electronic comments regarding this
document. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. To permit time for interested
persons to submit data, information, or
views on this subject, submit comments
by (see DATES). Where relevant, you
should annotate and organize your
comments to identify the specific
question addressed by the question
number referenced in the previous text.
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 (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Transcripts
Transcripts and summaries are
accessible at https://www.regulations.gov
VerDate Nov<24>2008
17:18 Mar 11, 2010
Jkt 220001
and on the Transparency Task Force
Web site at https://www.fda.gov/
transparency. Transcripts and
summaries may be viewed at the
Division of Dockets Management (see
ADDRESSES). They will also be available
in either hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: March 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–5377 Filed 3–11–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Director’s
Consumer Liaison Group.
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 Director’s Consumer Liaison Group.
Date: March 24–26, 2010.
Time: March 24, 2010, 2 p.m. to 6 p.m.
Agenda: Welcome, Overview of the Cancer
Genome Atlas, Expert Panel on the Cancer
Genome Atlas.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892.
Time: March 25, 2010, 8:30 a.m. to
5:30 p.m.
Agenda: Report of the DCLG Genomics
Working Group, Report on NCI Professional
Judgment Budget, Board Discussion about
Communicating with the Community about
Genomics Research.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892.
Time: March 26, 2010, 8:30 a.m. to 1 p.m.
Agenda: Board Discussion about Engaging
the Community around Genomics Research,
Discussion with NCI Director.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Benjamin Carollo, MPA,
Advocacy Relations Manager, Office of
Frm 00061
Fmt 4703
Sfmt 4703
Dated: February 26, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–5454 Filed 3–11–10; 8:45 am]
National Institutes of Health
PO 00000
Advocacy Relations, Building 31, Room
10A30, 31 Center Drive, MSC 2580, National
Cancer Institute, NIH, DHHS, Bethesda, MD
20892–2580. 301–496–0307.
CAROLLOB@MAIL.NIH.GOV.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/dclg/dclg.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(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,
Cancer Control, National Institutes of Health,
HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
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 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: Center for Scientific
Review Special Emphasis Panel; Cancer
Diagnostics and Therapeutics SBIR/STTR.
Date: March 18, 2010.
Time: 2 p.m. to 5 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: Lambratu Rahman, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahmanl@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 75, Number 48 (Friday, March 12, 2010)]
[Notices]
[Pages 11893-11894]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0247]
Food and Drug Administration Transparency Task Force; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is soliciting comments
from interested persons on ways in which FDA can increase transparency
between FDA and regulated industry.
DATES: Submit electronic or written comments by April 12, 2010.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Afia Asamoah, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, rm. 2220, Silver Spring, MD 20993-0002, 301-796-4625, FAX:
301-847-3531, e-mail: Afia.Asamoah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Transparency promotes accountability and provides information to
the public about government activities and initiatives. For FDA,
providing information to the public in a timely, user-friendly manner
is important to enhance the work of the agency.
Government transparency and accountability is a priority for the
Obama Administration. On January 21, 2009, President Obama instructed
executive departments and agencies to take appropriate action,
consistent with law and policy, to disclose information to the public
rapidly, and in a form that is easily accessible and user friendly.
Executive departments and agencies have been charged with harnessing
new technologies to make information about agency operations and
decisions available online and readily available to the public.
Executive departments and agencies have been asked to solicit public
input to identify information of greatest use to the public.
The Open Government Directive, issued by the Director of the Office
of Management and Budget on December 8, 2009, further instructed
executive departments and agencies to take specific actions to
implement a transparent, collaborative, and participatory government.
FDA has formed an internal Transparency Task Force to develop
recommendations for making useful and understandable information about
FDA activities and decisionmaking more readily available to the public.
The recommendations will focus on disclosing relevant information in a
timely manner and in a user-friendly format, and in a manner compatible
with the agency's goal of protecting confidential information, as
appropriate. As a part of this transparency initiative, the Task Force
has held two public meetings, on June 24, 2009, and November 3, 2009,
and established a public docket to seek public input on these issues.
As a result of the input the Task Force has received thus far, it has
decided to separate the Transparency Initiative into three phases: (1)
Creating a Web-based resource called ``FDA Basics,'' that provides
information about commonly misunderstood agency activities and
frequently asked questions; (2) improving FDA's disclosure of
information to the public; and (3) improving FDA's transparency to
regulated industry.
The first two phases are complete or well underway. ``FDA Basics''
was launched on FDA's Web site on January
[[Page 11894]]
12, 2010. The two public meetings held in 2009 and prior specific
requests for comments focused on how FDA can improve its disclosure to
the public. The Task Force soon plans to issue draft proposals related
to those issues for public comment. This document focuses on the third
phase of the transparency initiative.
II. Scope of the Meeting
The Task Force is collecting information on how to improve FDA's
transparency to regulated industry. It held three listening sessions
with members of regulated industry on January 21, 27, and 28, 2010. FDA
is making available transcripts and summaries of those listening
sessions (see section IV of this document), and seeks public comment
related to the issues raised in those sessions or other suggestions
related to FDA's transparency to regulated industry. FDA is
particularly interested in comments on how FDA can make improvements in
the following areas:
1. Training and education for regulated industry about the FDA
regulatory process in general and/or about specific new requirements.
2. The guidance development process.
3. Maintaining open channels of communication with industry
routinely and during crises.
4. Providing useful and timely answers to industry questions about
specific regulatory issues.
5. Communicating with sponsors during review of applications.
III. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. To permit time for interested persons to submit data,
information, or views on this subject, submit comments by (see DATES).
Where relevant, you should annotate and organize your comments to
identify the specific question addressed by the question number
referenced in the previous text. 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
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
IV. Transcripts
Transcripts and summaries are accessible at https://www.regulations.gov and on the Transparency Task Force Web site at
https://www.fda.gov/transparency. Transcripts and summaries may be
viewed at the Division of Dockets Management (see ADDRESSES). They will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.
Dated: March 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5377 Filed 3-11-10; 8:45 am]
BILLING CODE 4160-01-S
