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29768 Federal Register / Vol. 70, No.

99 / Tuesday, May 24, 2005 / Notices

Number of re- Average bur-


Number of re- Total burden
Instrument sponses per den hours per
spondents hours
respondent response

Program Reviewsa ........................................................................................... 36 1 0.5 18

Total for 2005 ........................................................................................... 981


a Reviews will be conducted with the locally based TA specialists.

Estimated Total Burden Hours: (OMB) for review and clearance under from animals, and perceived foodborne
2446.5. the Paperwork Reduction Act of 1995. illness and food allergy experience.
Estimated Annualized Burden for DATES: Fax written comments on the The majority of the questions to be
both the grantee and HEG site visits is collection of information by June 23, asked are identical to ones asked in the
1223.25 hours. This annual burden was 2005. 2001 Food Safety Survey (the 2001
calculated by dividing total burden survey). Because of recent national
ADDRESSES: OMB is still experiencing
hours by two years. consumer education campaigns about
significant delays in the regular mail,
Additional Information: Copies of the food safety and the large amount of
including first class and express mail,
proposed collection may be obtained by media attention to food safety issues in
and messenger deliveries are not being
writing to The Administration for the past few years, consumer attitudes,
accepted. To ensure that comments on
Children and Families, Office of knowledge, and practices are likely to
the information collection are received,
Information Services, 370 L’Enfant have changed greatly since the 2001
OMB recommends that written
Promenade, SW., Washington, DC survey. FDA needs current information
comments be faxed to the Office of
20447, Attn: ACF Reports Clearance to support consumer education
Information and Regulatory Affairs,
Officer. programs and regulatory development.
OMB, Attn: Fumie Yokota, Desk Officer
OMB Comment: OMB is required to Additionally, this data will be used to
for FDA, FAX: 202–395–6974.
make a decision concerning the measure changes in food safety handling
collection of information between 30 FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management practices and food allergy reactions as
and 60 days after publication of this part of the Healthy People 2010 food
document in the Federal Register. Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, safety objectives and allergen goals.
Therefore, a comment is best assured of New areas on the survey include
having its full effect if OMB receives it Rockville, MD 20857, 301–827–1223.
awareness of bovine spongiform
within 30 days of publication. Written SUPPLEMENTARY INFORMATION: In
encephalopathy and acrylamide,
comments and recommendations for the compliance with 44 U.S.C. 3507, FDA refrigeration practices, and updated
proposed information collection should has submitted the following proposed questions on washing practices for fresh
be sent directly to the following: Office collection of information to OMB for fruits and vegetables.
of Management and Budget, Paperwork review and clearance.
In the Federal Register of December 2,
Reduction Project, Attn: Desk Officer for 2005 Food Safety Survey 2004 (69 FR 70147), FDA published a
ACF, e-mail address:
Under section 903(b)(2) of the Federal 60-day notice requesting public
Katherine_T._Astrich@omb.eop.gov.
Food, Drug, and Cosmetic Act (21 U.S.C. comment on the information collection
Dated: May 19, 2005. 393(b)(2)), FDA is authorized to conduct provisions. Seven comments were
Robert Sargis, research relating to foods and to received. Four comments did not
Reports Clearance Officer. conduct educational and public address the information collection
[FR Doc. 05–10339 Filed 5–23–05; 8:45 am] information programs relating to the provisions, two comments supported
BILLING CODE 4184–01–M safety of the Nation’s food supply. FDA the proposed collection of information,
is planning to conduct a consumer and one comment contended that it is
survey about food safety under this a waste of government funds. The
DEPARTMENT OF HEALTH AND authority. The food safety survey will supporting comments requested that
HUMAN SERVICES provide information about consumers’ data from the survey be made more
food safety awareness, knowledge, widely available. None of the comments
Food and Drug Administration concerns, and practices. A nationally included any specific suggestions for
representative sample of 4,000 adults in the questionnaire or survey
[Docket No. 2004N–0516] households with telephones will be methodology.
selected at random and interviewed by FDA disagrees that the food safety
Agency Information Collection
telephone. This survey will include an survey is a waste of government funds.
Activities; Submission for Office of
oversample of Hispanics with a The data from the 2005 Food Safety
Management and Budget Review;
minimum of 500 Hispanics sampled. Survey will be used to evaluate the
Comment Request; 2005 Food Safety
Additionally, 200 initial Healthy People 2010 objectives for food
Survey
nonrespondents will be asked to safety and for allergens. Data from the
AGENCY: Food and Drug Administration, participate in a short version of the 2001 survey served as the baseline for
HHS. survey to conduct a nonresponse the Healthy People 2010 food safety and
ACTION: Notice. analysis. Participation will be voluntary. allergen objectives. Results from
Detailed information will be obtained previous food safety surveys were also
SUMMARY: The Food and Drug about food safety risk perception, used by FDA’s Center for Food Safety
Administration (FDA) is announcing perceived sources of food and Applied Nutrition to provide an
that a proposed collection of contamination, knowledge of particular assessment of the level of safety of
information has been submitted to the microorganisms, food handling consumer food preparation and
Office of Management and Budget practices, consumption of raw foods consumption practices, and levels of

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Federal Register / Vol. 70, No. 99 / Tuesday, May 24, 2005 / Notices 29769

awareness, concern, and knowledge articles and though government months a summary will be produced
related to food safety. publications. It is anticipated that for and made available to the public. Peer
FDA agrees that the data from the the first 6 months after collection, the reviewed journal articles are planned
food safety survey should be distributed data will be analyzed internally. After 6 following the summary.
publicly through peer review journal

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
Questionnaire Respondents per Response Responses Response Total Hours

Pretest 27 1 27 0.5 14

Screener 10,000 1 10,000 0.0167 167

Survey 4,000 1 4,000 0.30 1,200

Nonresponse 200 1 200 0.10 20

Total 1,401
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate is based on ACTION: Notice. infection). The existence of latent
FDA’s experience with the 2001 survey. infected cells poses a great challenge to
Prior to the survey being fielded, a small SUMMARY: The inventions listed below HIV therapy because (1) there are no
pretest of 27 individuals (each pretest are owned by an agency of the U.S. good existing means that can separate
lasting half an hour) will be conducted. Government and are available for the latent infected cells from the
FDA estimates that the survey will licensing in the U.S. in accordance with uninfected cells; (2) even when
require an average of 20 minutes per 35 U.S.C. 207 to achieve expeditious antiretroviral drugs are able to
respondent and that the variation in commercialization of results of completely suppress detectable HIV
burden across respondents will be federally-funded research and replication, these latent infected cells
small, based on average interview times development. Foreign patent will remain and HIV can subsequently
for the 2001 survey. The proposed applications are filed on selected complete the viral replication cycle to
number of respondents is 4,000, each of inventions to extend market coverage produce more virus. Since Resveratrol
whom will be asked to complete a one- for companies and may also be available and its derivatives can activate lytic
time telephone interview that requires for licensing. replication from latent infected cells via
no preparation time. Additionally, 200 ADDRESSES: Licensing information and its effects on Erk1/2 signaling,
initial nonrespondents will be asked to copies of the U.S. patent applications Resveratrol and its derivatives may lead
participate in a short version of the listed below may be obtained by writing to therapies in which Resveratrol and/
survey to conduct a nonresponse to the indicated licensing contact at the or its derivatives is given together with
analysis. The screener is estimated to Office of Technology Transfer, National highly active antiretroviral therapy in an
take 1 minute or less per response for Institutes of Health, 6011 Executive effort to decrease or eliminate the
a total screener burden of 4,000 Boulevard, Suite 325, Rockville, reservoir of latent infected cells with
respondents plus 6,000 ineligibles Maryland 20852–3804; telephone: (301) hope of perhaps eventually curing a
screened, taking an estimated 167 hours. 496–7057; fax: (301) 402–0220. A signed patient of HIV infection.
The total hours reporting burden to the Confidential Disclosure Agreement will
Treatment of Human Viral Infections
public is the sum of the pretest, the be required to receive copies of the
(Proteosome Inhibitors)
screener, the completed surveys, and patent applications.
the nonresponse surveys, resulting in an Drs. Steven Zeichner and Vyjayanthi
Treatment of Human Viral Infections Krishnan (NCI).
estimated public reporting burden of
(Resveratrol) U.S. Provisional Application No. 60/
1,401 hours.
Dated: May 17, 2005.
Drs. Steven Zeichner and Vyjayanthi 587,810 filed 13 Jul 2004 (DHHS
Krishnan (NCI). Reference No. E–280–2004/0–US–01).
Jeffrey Shuren,
U.S. Provisional Application No. 60/ Licensing Contact: Sally Hu; 301/435–
Assistant Commissioner for Policy. 588,013 filed 13 Jul 2004 (DHHS 5606; hus@mail.nih.gov.
[FR Doc. 05–10289 Filed 5–23–05; 8:45 am] Reference No. E–279–2004/0–US–01). This application describes the
BILLING CODE 4160–01–S Licensing Contact: Sally Hu; 301/435– methods for treating or preventing an
5606; hus@mail.nih.gov. HIV infection by the administration of
This application describes the proteosome inhibitors and their
DEPARTMENT OF HEALTH AND
methods for treating or preventing an derivatives. It has been known that HIV,
HUMAN SERVICES
HIV infection by the administration of once it infects a cell, integrates into the
National Institutes of Health an Egr 1 activator called Resveratrol (3, cellular genome and can (1) rapidly
5, 4″-trihydroxystilbene) and its undergo lytic infection, or (2) lay
Government-Owned Inventions; derivatives. It has been known that HIV, dormant for a period of time (latent
Availability for Licensing once it infects a cell, integrates into the infection). The existence of latent
cellular genome and can (1) rapidly infected cells poses a great challenge to
AGENCY: National Institutes of Health, undergo lytic infection, or (2) lay HIV therapy because (1) there are no
Public Health Service, DHHS. dormant for a period of time (latent good existing means that can separate

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