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Federal Register / Vol. 71, No.

137 / Tuesday, July 18, 2006 / Notices 40721

involving individual Federal Reserve send comments to Seleda Perryman, conditions. Participants in the treatment
System employees. CDC Assistant Reports Clearance condition, will be exposed to campaign
2. Any items carried forward from a Officer, 1600 Clifton Road, MS–D74, materials including radio
previously announced meeting. Atlanta, GA 30333 or send an e-mail to advertisements, a billboard, and an
FOR FURTHER INFORMATION CONTACT: omb@cdc.gov. informational booklet that will be
Michelle Smith, Director, or Dave Comments are invited on: (a) Whether distributed over the Internet. Thus the
Skidmore, Assistant to the Board, Office the proposed collection of information study participants’ exposure will occur
of Board Members at 202–452–2955. is necessary for the proper performance under controlled conditions, without
SUPPLEMENTARY INFORMATION: You may of the functions of the agency, including the distractions and variability of
call 202–452–3206 beginning at whether the information shall have potential exposure in the real world. As
approximately 5 p.m. two business days practical utility; (b) the accuracy of the part of the advertisement stimuli
before the meeting for a recorded agency’s estimate of the burden of the package, the billboard advertisement
announcement of bank and bank proposed collection of information; (c) will appear as part of the online log-in
holding company applications ways to enhance the quality, utility, and for each stimuli session in order to
scheduled for the meeting; or you may clarity of the information to be simulate the appearance of a sign.
contact the Board’s Web site at http:// collected; and (d) ways to minimize the Therefore, we do not estimate any
www.federalreserve.gov for an electronic burden of the collection of information additional burden for exposure to the
announcement that not only lists on respondents, including through the billboard advertisement.
applications, but also indicates use of automated collection techniques
or other forms of information Key outcomes related to the HTSMC
procedural and other information about will be measured in two follow-up
the meeting. technology. Written comments should
be received within 60 days of this surveys. The first follow-up survey will
Board of Governors of the Federal Reserve notice. occur 2 weeks after the baseline survey.
System, July 14, 2006. The second follow-up survey will occur
Robert deV. Frierson, Proposed Project 6 weeks after the baseline survey.
Deputy Secretary of the Board. Evaluation of the HIV Testing Social Comparisons of changes in these
[FR Doc. 06–6351 Filed 7–14–06; 2:44 pm] Marketing Campaign (HTSMC)—New— outcomes would then be made between
BILLING CODE 6210–01–S National Center for HIV/AIDS, Viral participants in the treatment and control
Hepatitis, STD, and TB Prevention conditions. Findings from this study
(NCHHSTP), Coordinating Center for will be used by CDC and its partners to
DEPARTMENT OF HEALTH AND Infectious Diseases (CCID), Centers for inform current and future program
HUMAN SERVICES Disease Control and Prevention (CDC). activities.
Background and Brief Description We expect a total of 1,630 participants
Centers for Disease Control and to complete the baseline survey. The
Prevention This project involves the evaluation of
the HIV Testing Social Marketing 1,630 participants who complete the
[60Day-06–06BL] Campaign (HTSMC), a CDC-sponsored baseline survey will be randomly
social marketing campaign aimed at assigned to the treatment or control
Proposed Data Collections Submitted condition. 815 participants (the
increasing HIV testing rates among
for Public Comment and treatment condition) will be exposed to
young, single, African American
Recommendations the radio ad and booklet. Of the 1,630
women. The CDC has designed an
In compliance with the requirement efficacy study to evaluate the HTSMC participants who completed the baseline
of section 3506(c)(2)(A) of the and its messages under controlled survey, we expect 1,140 to complete the
Paperwork Reduction Act of 1995 for conditions. The study entails selecting a first follow-up survey. Of the 1,140 who
opportunity for public comment on sample of single African American complete the first follow-up survey, we
proposed data collection projects, the females, ages 18 to 34, with less than 4 expect 800 to complete the second
Centers for Disease Control and years of college education and collecting follow-up survey, which will have fewer
Prevention (CDC) will publish periodic baseline data on their knowledge, questions than the first follow-up survey
summaries of proposed projects. To attitudes, beliefs, intentions, and because it will only pertain to questions
request more information on the behaviors related to HIV testing. The about behavior change and selected
proposed projects or to obtain a copy of study represents an ‘‘efficacy’’ behavioral intentions.
the data collection plans and methodology in that participants will be There are no costs to the respondents
instruments, call 404–639–5960 and divided into treatment and control other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS


Average
Responses Total
Number of burden per
Respondents per burden
respondents response (in
respondent hours
hours)

Baseline survey ............................................................................................................. 1,630 1 15/60 408


Radio ad stimuli viewing ............................................................................................... 815 1 18/60 245
Booklet reading ............................................................................................................. 815 1 15/60 204
Follow-up survey 1 ........................................................................................................ 1,140 1 15/60 285
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Follow-up survey 2 ........................................................................................................ 800 1 5/60 67

Total ....................................................................................................................... .................... .................... ...................... 1,209

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40722 Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices

Dated: July 10, 2006. authorization (EUA) must demonstrate categories of respondents which
Joan F. Karr, that, based on the totality of the include: (1) Those who file a Request for
Acting Reports Clearance Officer, Centers for scientific evidence available to the Consideration for an EUA after a
Disease Control and Prevention. Commissioner, including data from determination of actual or potential
[FR Doc. E6–11340 Filed 7–17–06; 8:45 am] adequate and well-controlled clinical emergency and, in lieu of submitting the
BILLING CODE 4163–18–P trials (if available), it is reasonable to data, provide reference to a pending or
believe that the product may be effective approved application; (2) those who file
in diagnosing, treating, or preventing a a Request for Consideration for an EUA
DEPARTMENT OF HEALTH AND serious or life-threatening disease or and the data after a determination of
HUMAN SERVICES condition (21 U.S.C. 360bbb–3(c)). actual or potential emergency, without
Although the exact type and amount of reference to a pending or approved
Food and Drug Administration data needed to support an EUA may application; (3) those who submit data
[Docket No. 2004D–0333] vary depending on the nature of the to FDA on a candidate EUA product,
declared emergency and the nature of which is subject to a pending or
Agency Information Collection the candidate product, FDA approved application, prior to a
Activities; Submission for Office of recommends that a request for determination of actual or potential
Management and Budget Review; consideration for an EUA include emergency; (4) those who submit data to
Comment Request; Draft Guidance: scientific evidence evaluating the FDA prior to a determination of actual
Emergency Use Authorization of product’s safety and effectiveness, or potential emergency about a
Medical Products including the adverse event profile for candidate EUA product for which there
diagnosis, treatment, or prevention of is no pending or approved application;
AGENCY: Food and Drug Administration, the serious or life-threatening disease or (5) manufacturers of an unapproved
HHS. condition, as well as data and other EUA product who must report to FDA
ACTION: Notice. information on safety, effectiveness, regarding such activity; and (6) State
risks and benefits, and (to the extent and local public health officials who
SUMMARY: The Food and Drug available) alternatives. carry out an activity related to an
Administration (FDA) is announcing Under section 564 of the act, the unapproved EUA product (e.g.,
that a proposed collection of Commissioner may establish conditions administering the product to civilians)
information has been submitted to the on the approval of an EUA. Section and who must report to FDA regarding
Office of Management and Budget 564(e) requires the Commissioner (to the such activity.
(OMB) for review and clearance under extent practicable given the For purposes of estimating the burden
the Paperwork Reduction Act of 1995. circumstances of the emergency) to of recordkeeping, FDA has calculated
DATES: Fax written comments on the establish certain conditions on an the anticipated burden on
collection of information by August 17, authorization that the Commissioner manufacturers of unapproved products
2006. finds necessary or appropriate to protect authorized for emergency use. The
ADDRESSES: OMB is still experiencing the public health and permits the agency anticipates that the Federal
significant delays in the regular mail, Commissioner to establish other Government will perform some of the
including first class and express mail, conditions that he finds necessary or additional recordkeeping necessary for
and messenger deliveries are not being appropriate to protect the public health. unapproved products (e.g., related to the
accepted. To ensure that comments on Conditions authorized by section 564(e) administration of unapproved EUA
the information collection are received, of the act include, for example: products to military personnel). FDA
OMB recommends that written Requirements for information also anticipates that some State and
comments be faxed to the Office of dissemination to health care providers local public health officials may be
Information and Regulatory Affairs, or authorized dispensers and product required to perform additional
OMB, Attn: FDA Desk Officer, FAX: recipients; adverse event monitoring recordkeeping (e.g., related to the
and reporting; data collection and administration of unapproved EUA
202–395–6974.
analysis; recordkeeping and records products to civilians) and calculated a
FOR FURTHER INFORMATION CONTACT: access; restrictions on product recordkeeping burden for those
Jonna Capezzuto, Office of Management advertising, distribution, and activities.
Programs (HFA–250), Food and Drug administration; and limitations on good No burden was attributed to reporting
Administration, 5600 Fishers Lane, manufacturing practices requirements. or recordkeeping for unapproved uses of
Rockville, MD 20857, 301–827–4659. Some conditions, the statute specifies, approved products, because those
SUPPLEMENTARY INFORMATION: In are mandatory to the extent practicable products already are subject to approved
compliance with 44 U.S.C. 3507, FDA for authorizations of unapproved collections of information (adverse
has submitted the following proposed products and discretionary for experience reporting for biological
collection of information to OMB for authorizations of unapproved uses of products is approved under OMB
review and clearance. approved products. Moreover, some control number 0910–0308 through May
conditions may apply to manufacturers 31, 2005; adverse drug experience
Draft Guidance: Emergency Use
of an EUA product, while other reporting is approved under OMB
Authorization of Medical Products
conditions may apply to any person control number 0910–0230 through
The Federal Food, Drug, and Cosmetic who carries out any activity for which September 30, 2005; and investigational
Act (the act) permits the Commissioner the authorization is issued. Section 564 new drug applications (IND) regulations
of FDA (the Commissioner) to authorize of the act also gives the Commissioner are approved under OMB control
the use of unapproved medical products authority to establish other conditions number 0910–0014 through January 31,
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or unapproved uses of approved on an authorization that the 2006), and any additional burden
medical products during an emergency Commissioner finds to be necessary or imposed by this proposed collection
declared under section 564 of the act (21 appropriate to protect the public health. would be minimal. Thus, FDA estimates
U.S.C. 360bbb–3). The data to support For purposes of estimating the burden the burden of this collection of
issuance of an emergency use of reporting, FDA has established six information as follows:

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