Attachment B - Federal Register Notice - 60 Day

Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
Dated: December 10, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–24316 Filed 12–14–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–0210]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance

Officer at (404) 639–4766 or send an email to [email protected]. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
List of Ingredients Added to Tobacco
in the Manufacture of Cigarette
Products—Reinstatement with Change—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Cigarette smoking is the leading
preventable cause of premature death
and disability in the United States. Each
year more than 440,000 premature
deaths occur as the result of smoking
related diseases.
The Comprehensive Smokeless
Tobacco Health Education Act of 1986

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(15 U.S.C. 4401 et seq., Pub. L. 99–252)
requires each person who manufactures,
packages, or imports cigarettes to
provide the Secretary of Health and
Human Services (HHS) with a list of
ingredients added to tobacco in the
manufacture of cigarettes. This
legislation also authorizes HHS to
undertake research, and submit an
annual report to Congress (as deemed
appropriate) discussing the health
effects of these ingredients in smokeless
tobacco products. HHS has delegated
responsibility for the implementation of
this Act to CDC’s Office on Smoking and
Health (OSH). Respondents report the
required information to CDC once per
year according to Tobacco Ingredient
and Nicotine Reporting instructions
posted on the OSH web site. Changes
effective with this reinstatement relate
to the redesign of the OSH web site.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 930.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Number of
respondents

Number of
responses
per
respondent

Average burden per response
(in hours)

Smokeless Tobacco Manufacturers, Packagers, and Importers ................................................

143

1

6.5

Dated: December 10, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–24323 Filed 12–14–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–08–0669]

ebenthall on PROD1PC69 with NOTICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,

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15:28 Dec 14, 2007

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1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluation of State Nutrition and
Physical Activity Programs to Prevent
Obesity and Other Chronic Diseases—
Reinstatement with Change—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDHP),
Centers for Disease Control and
Prevention (CDC).

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Background and Brief Description:
The ‘‘State Nutrition and Physical
Activity Programs to Prevent Obesity
and Other Chronic Diseases’’ (NPAO)
project was established by CDC to
prevent and control obesity and other
chronic diseases by supporting States in
the development and implementation of
nutrition and physical activity
interventions, particularly through
population-based strategies such as
policy-level changes, environmental
supports and the social marketing
process. The goal of the programs in this
project is to attain population-based
behavior change such as increased
physical activity and better dietary
habits; this leads to a reduction in the
prevalence of obesity, and ultimately to
a reduction in the prevalence of chronic
diseases.
Evaluation questions for ‘‘State
Nutrition and Physical Activity
Programs to Prevent Obesity and Other
Chronic Diseases’’ have been previously
approved under OMB control no. 0920–
0669, which is scheduled to expire
January 31, 2008. CDC seeks OMB
approval to reinstate the evaluation in
2008 with changes, in response to
feedback from users and stakeholders
based on experience with the previously

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Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
• Intervention.
• Evaluation.
Within each of these areas, the plan
identifies specific evaluation questions
that have been chosen for study. The
evaluation questions are asked of the
funded states via a web-based data
collection system supported by an

approved questions. The evaluation is
designed to focus on the recipient
activities as outlined in the original
funding announcement:
• Capacity building.
• Collaboration.
• Planning.
• Monitoring the burden of obesity.

electronic database every 6 months
during the funding cycle. The project
will continue to be conducted over a 3year period.
There are no costs to respondents
except their time to participate in the
survey.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

Average burden per response (in
hours)

Total burden
(in hours)

States participating in NPAO ...........................................................................

28

2

12

672

Total ..........................................................................................................

........................

........................

........................

672

Dated: December 11, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–24325 Filed 12–14–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0459]

International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 3 on Test for
Particulate Contamination: Subvisible
Particles General Chapter; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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Number of
responses per
respondent

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 3: Test for
Particulate Contamination: Subvisible
Particles General Chapter.’’ The draft
guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides the results
of the ICH Q4B evaluation of the Test
for Particulate Contamination:
Subvisible Particles General Chapter
harmonized text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The draft guidance conveys
recognition of the three pharmacopoeial

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methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The draft guidance is intended to
recognize the interchangeability
between the local regional
pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This is the third annex to the
core Q4B guidance, which was made
available in draft in the Federal Register
of August 8, 2006 (71 FR 45059).
Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 15, 2008.

DATES:

Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
ADDRESSES:

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for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King,
Sr., Center for Drug Evaluation and
Research (HFD–003), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, rm. 3542, Silver Spring,
MD 20993–0002, 301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–20), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–435–5681.
Regarding the ICH: Michelle Limoli,
Office of International Programs (HFG–
1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–4480.
SUPPLEMENTARY INFORMATION:

I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,

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