ATT2_60dFRN

Attachment 2

Federal Register Notice, Volume 73, No. 70, pp. 19507-08, April 10, 2008

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Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices
Proposed Project
Formative Evaluation of Adults’ and
Children’s Views Related to Promotion
of Healthy Food Choices—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In FY 2004, Congress directed the
Centers for Disease Control and
Prevention (CDC) to conduct formative
research on the attitudes of children and
parents regarding nutrition behavior and
the characteristics of effective marketing
of foods to children to promote healthy
food choices. In response, CDC will
work with a contractor to conduct focus
groups to explore barriers and

motivations to the adoption and
maintenance of healthy food choices
among children at different
developmental stages. Current literature
and opinion-leaders both strongly
suggest that ‘‘tweens’’ (ages 9–12)
greatly influence their parents’ and
younger siblings’ nutritional decisions.
The focus groups will also explore the
topic of family interactions around
decision-making about food choices.
The information gathered will be used
to develop, refine, and modify messages
and strategies to increase healthy food
choices by children and parents.
A total of 90 focus groups will be
conducted in three phases: Phase 1 will
address tweens and parents of tweens;
Phase 2 will focus on children 5–8 years
old and their parents; and Phase 3 focus

groups will be conducted with parents
of children ages 1–4 years old. Thirtysix focus groups will be conducted in
Phase 1; 36 focus groups will be
conducted in Phase 2; and 18 focus
groups will be conducted in Phase 3.
All focus groups will incorporate
appropriate representation of diverse
ethnic groups, and the groups will be
held in several cities to ensure broad
geographic representation. Participants
will be recruited by focus group
facilities utilizing their database to
solicit and screen interested parties.
Each focus group discussion will be
limited to no more than two hours.
There is no cost to respondents other
than their time. The total estimated
annualized burden hours are 1,556.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Children ...........................................................

Screener D1 for Parent & Child Groups ........
Screener D2 for Child Only Groups ...............
Focus Group Moderator’s Guide for Children/
Youth.
Screener D1 for Parent & Child Groups ........
Screener D2 for Child Only Groups ...............
Screener D3 for Parent Only Groups ............
Focus Group Moderator’s Guide for Parents

Parents ............................................................

Dated: April 1, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–7571 Filed 4–9–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–08–08AX]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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No. of
respondents

Type of respondents

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 or send
comments to Maryam Daneshvar, Acting
CDC Reports Clearance Officer, 1600

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Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
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
Nationally Notifiable Sexually
Transmitted Disease (STD) Morbidity
Surveillance—New—Division of STD
Prevention (DSTDP), National Center for
HIV, Viral Hepatitis, STD and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).

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No. of
responses per
respondent

Average
burden
(in hours)

384
384
384

1
1
1

3/60
3/60
2

192
192
288
336

1
1
1
1

7/60
7/60
7/60
2

Background and Brief Description
Because the STD epidemiology in the
United States is changing rapidly, CDC
must monitor disease indicators that are
not currently included in the STD
surveillance currently being
implemented. CDC is proposing a new
electronic information collection which
will include information elements that
will be integrated into the existing
nationally notifiable STDs. These new
information elements are beyond the
scope of the OMB-approved collection
called Weekly and Annual Morbidity
and Mortality Reports (MMWR, OMB
#0920–0007). The new collection will
be epidemiologically superior to the
existing system and will provide
evidence to better define STD
distribution and epidemiology in the
United States. The proposed
surveillance system will modify several
data elements currently included in the
MMWR collection and add others to
produce a new set of sensitive
indicators. This new surveillance will
provide the evidence to enhance our
understanding of STDs, develop
intervention strategies, and evaluate the
impact of ongoing control efforts.
CDC works closely with state and
local STD control programs to monitor

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Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices

and respond to STD outbreaks and
trends in STD-associated risk behavior.
Users of data include, but are not
limited to, congressional offices, state
and local health agencies, health care
providers, and other health-related
groups.
CDC disseminates all STD
surveillance information through the
MMWR series of publications, including

the MMWR, the CDC Surveillance
Summaries, the Recommendations and
Reports, and the annual Summary of
Notifiable Diseases, United States.
Additionally, DSTDP publishes an
annual STD-specific surveillance
summary and supplements in hard copy
on CD–ROM and on the Internet http://
www.cdc.gov/nchstp/dstd/Stats_
Trends/Stats_and_Trends.htm.

CDC will use the findings from this
and other STD surveillance to develop
guidelines, control strategies, and
impact measures that monitor trends in
STDs in the United States.
We expect a total of 57 sites in state,
city, and territory health departments
will be submitting STD morbidity
information to CDC each week.

ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents

Types of data collection

Average
burden per
response
(in hours)

Total burden
in hours

States ...............................................................................................................
Territories .........................................................................................................
Cities ................................................................................................................

50
5
2

52
52
52

20/60
20/60
20/60

867
87
35

Totals ........................................................................................................

57

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

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

989

Dated: April 3, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–7575 Filed 4–9–08; 8:45 am]

should be identified with the OMB
control number 0910–0613. Also
include the FDA docket number found
in brackets in the heading of this
document.

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FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.

Food and Drug Administration
[Docket No. FDA–2008–N–0027] (formerly
Docket No. 2007N–0495)

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
User Fee Amendments of 2007;
Foreign Small Business Qualification
Certification, Form FDA 3602A
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

mstockstill on PROD1PC66 with NOTICES

Number of
responses per
respondent

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 12,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments

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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.

SUPPLEMENTARY INFORMATION:

Medical Device User Fee Amendments
of 2007; Foreign Small Business
Qualification Certification, Form FDA
3602A—(OMB Control Number 0910–
0613)—Extension
The FDA Amendments Act of 2007
includes the ‘‘Medical Device User Fee
Amendments of 2007’’ (the 2007
Amendments), which reauthorizes
medical device user fees for fiscal years
(FY) 2008 through 2012 and which
makes significant changes to the
medical device user fee provisions of
the act. The 2007 Amendments provide
a new way for a foreign business to
qualify as a small business eligible to
pay a significantly lower fee when a
medical device user fee must be paid.
Before passage of the 2007
Amendments, the only way a business
could qualify as a small business was to
submit a Federal (U.S.) income tax
return showing its gross receipts or sales
that did not exceed a statutory
threshold, (currently $100 million). If a
business could not provide a Federal
income tax return, it did not qualify as

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a small business and had to pay the
standard (full) fee. Because many
foreign businesses have not, and cannot,
file a Federal (U.S.) income tax return,
this requirement has effectively
prevented those businesses from
qualifying for the small business fee
rates. Thus, foreign governments,
including the European Union, have
objected.
In lieu of a Federal income tax return,
the 2007 Amendments will allow a
foreign business to qualify as a small
business by submitting a certification
from its national taxing authority, the
foreign equivalent of our Internal
Revenue Service. This certification,
referred to as a ‘‘National Taxing
Authority Certification,’’ must:
• Be in English;
• Be from the national taxing
authority of the country in which the
business is headquartered;
• Provide the business’ gross receipts
or sales for the most recent year, in both
the local currency and in U.S. dollars,
and the exchange rate used in
converting local currency to U.S.
dollars;
• Provide the dates during which the
reported receipts or sales were
collected; and
• Bear the official seal of the national
taxing authority.
The new FDA Form 3602A, ‘‘FY 2008
MDUFMA Foreign Small Business
Qualification Certification,’’ will collect
the information required by the statute
and allows a foreign business to qualify
for the same small business benefits as
a domestic U.S. business.
In the Federal Register of January 15,
2008 (73 FR 2503), FDA published a 60day notice requesting public comment
on the information collection

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