[Federal Register: June 16, 2004 (Volume 69, Number 115)]
[Notices]
[Page 33826-33828]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn04-107]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Interim HIV Content Guidelines for AIDS-Related Materials,
Pictorials, Audiovisuals, Questionnaires, Survey Instruments,
Marketing, Advertising and Web Site Materials, and Educational Sessions
in CDC School-Based Assistance Programs
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).
ACTION: Notice for public comment.
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SUMMARY: The purpose of this document is to seek public comment on
proposed Interim HIV Content Guidelines, entitled ``Content of AIDS-
Related written materials, pictorials, audiovisuals, questionnaires,
survey instruments, and educational sessions in CDC school-based
assistance programs'' and to seek public comment on the Interim
Guidelines. The purpose of these Guidelines are to (1) Address advances
in technology (mainly the advent of the Internet and the World Wide
Web); (2) increase grantee accountability; (3) be consistent with new
public law; and (4) provide clarification for school-based assistance
programs in the development of AIDS-related materials, pictorials,
audiovisuals, questionnaires, survey instruments, marketing,
advertising, and Web site materials, and educational sessions.
DATES: Submit comments on or before August 16, 2004.
ADDRESSES: Address all comments concerning this notice to Interim HIV
Content Guidelines Comments (School-based Assistance Programs), Centers
for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop
E56, Atlanta, Georgia 30333. Comments may be e-mailed to
HIVComments@cdc.gov or faxed to (404) 639-3125.
FOR FURTHER INFORMATION CONTACT: Tim Hack, Centers for Disease Control
and Prevention, National Center for Chronic Disease Prevention and
Health Promotion, 1600 Clifton Road, NE., Mailstop K29, Atlanta,
Georgia 30333. Telephone: (770) 488-3249.
SUPPLEMENTARY INFORMATION: The Centers for Disease Control and
Prevention (CDC) has provided funds for HIV prevention programs since
1985. Since then, CDC, as part of the terms and conditions for
receiving these funds, has required that all HIV educational and
related materials must be reviewed by a Program Review Panel (PRP)
designated by the recipient. The purpose of this requirement is to
ensure a careful consideration of the content and intended audience of
the materials and programs because education about preventing HIV
transmission involves effectively presenting information appropriate
for the specific audience. On June 15, 1992, CDC published in the
Federal Register (57 FR 26742) a guidance document for this review
entitled ``Content of AIDS-related written materials, pictorial,
audiovisuals, questionnaires, survey instruments, and educational
sessions in Centers for Disease Control assistance programs''.
Currently, those Guidelines are in effect for school based assistance
programs.
In this notice, CDC is proposing a separate guidance document for
school-based assistance programs. The purpose of this document is to
(1) address advances in technology (mainly the advent of the Internet
and the World Wide Web); (2) increase grantee accountability; (3) be
consistent with new public law; and (4) provide clarification for
school-based assistance programs. CDC anticipates publishing a Final
Guidance document for school-based assistance programs within 120
[[Page 33827]]
days after the conclusion of the comment period.
Summary and Explanation of Guidelines for School-Based Assistance
Programs
The Interim HIV Content Guidelines for school-based assistance
programs:
(1) Require review and approval of HIV/AIDS educational materials
placed on an organization's Web site. When the requirements were
developed for local review of HIV/AIDS education materials, the
Internet and World Wide Web were not used by the general public as a
major source of information as it is today. As a result, CDC is
proposing revisions to the Guidelines to require that HIV/AIDS
educational materials placed on a grantee's Web site be reviewed and
approved by the organization's designated Program Review Panel (PRP).
This requirement will not apply to materials developed by the U.S.
Department of Health and Human Services.
(2) Require that funded recipients ensure the PRP has determined
that the materials comply with section 317P of the Public Health
Service Act. Section 317P was added to the Public Health Service Act in
2000. This section states, in part, that ``education materials * * *
that are specifically designed to address sexually transmitted diseases
* * * shall contain medically accurate information regarding the
effectiveness or lack of effectiveness of condoms in preventing the
sexually transmitted disease the materials are designed to address.''
(3) Clarify the requirement of the PRP by requiring identification
of a PRP of no less than five persons who represent a reasonable cross-
section of the jurisdiction in which the program is based to ensure
better representation of the community to be served. The current
Guidelines require the identification of a PRP of no less than five
persons who represent a reasonable cross-section of the general
population. The proposed Guidelines require the identification of a PRP
of no less than five persons who represent a reasonable cross-section
of the jurisdiction in which the program is based. This clarification
should ensure better representation of the community to be served.
(4) Require each recipient to identify at least one PRP,
established by a State, territory, or local educational agency from the
jurisdiction of the recipient. This revision provides jurisdictions
with the flexibility to establish the number of PRPs to meet demand.
(5) Require PRPs to ensure that the title of materials developed
and submitted for review reflects the content of the activity or
program. This revision will ensure that materials and their contents
are clearly stated to the audience.
(6) Require funded recipients to include a certification that
accountable State, territorial or local education officials have
independently reviewed education materials for compliance with sections
2500 and 317P of the Public Health Service Act. This is a new
requirement in the revised Guidelines and follows the same rationale of
Miller v. California, 413 U.S. 15, 93 S.Ct. 2607 (1973) that defines
`obscenity' by looking to the average person, applying contemporary
community standards, as a way to ensure that material would be judged
by its impact on an average person, rather than a particularly
susceptible or sensitive person, or a totally insensitive one. The
review responsibility, in the proposed Guidelines, is placed at the
State and local level, specifically with State and local educational
officials.
(7) Develop a separate guidance document for school-based
assistance programs. The current Guidelines apply to school-based
assistance programs as well as regional, state, territorial, local, and
community assistance programs. The Interim Guidelines separate the
guidance into two documents for ease of use and clarity.
Dated: June 7, 2004.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control
and Prevention.
Interim HIV Content Guidelines for AIDS-Related Written Materials,
Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and
Educational Sessions for CDC School-Based Assistance Programs
I. Basic Principles
Controlling the spread of HIV infection and the occurrence of AIDS
requires the promotion of individual behaviors that eliminate or reduce
the risk of acquiring and spreading the virus. Messages must be
provided to the public that emphasize the ways by which individuals can
protect themselves from acquiring the virus. These methods include
abstinence from illegal use of IV drugs as well as from sexual
intercourse except in a mutually monogamous relationship with an
uninfected partner.
For those individuals who do not or cannot cease risky behavior,
methods of reducing their risk of acquiring or spreading the virus must
also be communicated. Such messages are often controversial. The
principles contained in this document are intended to provide guidance
for the development and use of HIV/AIDS-related educational materials
developed or acquired in whole or in part using CDC HIV prevention
funds, and to require the establishment of at least one Program Review
Panel by State, territorial, or local education agencies to consider
the appropriateness of educational materials developed for use by, or
used in, school settings. State, territorial, and local education
agencies may, if they deem it appropriate, establish multiple Program
Review Panels to consider the appropriateness of educational materials
developed for use by, or used in, school settings.
A. Written materials (e.g., pamphlets, brochures, curricula,
fliers), audiovisual materials (e.g., motion pictures and videotapes),
pictorials (e.g., posters and similar educational materials using
photographs, slides, drawings, or paintings) and marketing,
advertising, Web site-based HIV/AIDS educational materials,
questionnaires or survey instruments should use terms, descriptors, or
displays necessary for the intended audience to understand dangerous
behaviors and explain practices that eliminate or reduce the risk of
HIV transmission.
B. Written materials, audiovisual materials, pictorials, and
marketing, advertising, Web site-based HIV/AIDS educational materials,
questionnaires or survey instruments should be reviewed by a Program
Review Panel established by State, territorial or local education
agencies, consistent with the provisions of section 2500(b),(c), and
(d) of the Public Health Service Act, 42 U.S.C. section 300ee(b), (c),
and (d), as follows:
``SEC. 2500. USE OF FUNDS.
(b) Contents of Programs.--All programs of education and
information receiving funds under this title shall include
information about the harmful effects of promiscuous sexual activity
and intravenous substance abuse, and the benefits of abstaining from
such activities.
(c) Limitation.--None of the funds appropriated to carry out
this title may be used to provide education or information designed
to promote or encourage, directly, homosexual or heterosexual sexual
activity or intravenous substance abuse.
(d) Construction.--Subsection (c) may not be construed to
restrict the ability of an educational program that includes the
information required in subsection (b) to provide accurate
information about various means to reduce an individual's risk of
exposure to, or to transmission of, the etiologic agent for acquired
immune deficiency syndrome, provided that any informational
materials used are not obscene.''
C. Educational sessions should not include activities in which
attendees
[[Page 33828]]
participate in sexually suggestive physical contact or actual sexual
practices.
D. Program Review Panels must ensure that the title of materials
developed and submitted for review reflects the content of the activity
or program.
E. When HIV materials include a discussion of condoms, the
materials must comply with section 317P of the Public Health Service
Act, 42 U.S.C. section 247b-17, which states in pertinent part:
``educational materials * * * that are specifically designed to
address STDs * * * shall contain medically accurate information
regarding the effectiveness or lack of effectiveness of condoms in
preventing the STD the materials are designed to address.''
F. Messages provided to young people in schools and in other
settings should be guided by principles contained in ``Guidelines for
Effect School Health Education to Prevent the Spread of AIDS'' http://www.cdc.gov/HealthyYouth/sexualbehaviors/guidelines/guidelines.htm
.
II. Program Review Panel
Each recipient will be required to establish at least one Program
Review Panel. These Program Review Panels will review and approve all
written materials, pictorials, audiovisuals, marketing, advertising,
and Web site materials, questionnaires or survey instruments (except
questionnaires or survey instruments previously reviewed by an
Institutional Review Board), and proposed educational group session
activities to be used under the project plan. The requirement applies
regardless of whether the applicant plans to conduct the total program
activities or plans to have part of them conducted through other
organization(s) or the program activities involve creating unique
materials or using/distributing modified or intact materials already
developed by others. Materials developed by the U.S. Department of
Health and Human Services do not need to be reviewed by a panel.
Members of a Program Review Panel should understand how HIV is and is
not transmitted and understand the epidemiology and extent of the HIV/
AIDS problem in the local population and the specific audiences for
which materials are intended.
A. The Program Review Panel(s) will be guided by the CDC Basic
Principles (see section I above) in conducting such reviews. The panel
is authorized to review materials only and is not empowered either to
evaluate the proposal as a whole or to replace any internal review
panel or procedure of the recipient organization or local governmental
jurisdiction.
B. Panels established by CDC-funded state, territorial and local
education agencies, which review materials for use with school-based
populations shall include a designated representative from the state,
territorial, or local health department and should include
representatives from each of these groups: teachers, school
administrators, parents, and students. The identity of members of the
Program Review Panel(s), including their names, occupations and any
organizational affiliations that were considered in their selection for
the panel shall be submitted to CDC when a cooperative agreement/grant
is awarded.
1. Since Program Review Panels review materials for many intended
audiences, no single intended audience shall dominate the composition
of the Program Review Panel, except as provided in subsection c below.
In addition:
a. Panels that review materials intended for a specific audience
should draw upon the expertise of individuals who can represent
cultural sensitivities and language of the intended audience, either
through representation on the panel or as consultants to the panels.
b. Panels must ensure that the title of materials developed and
submitted for review reflect the content of the activity or program.
c. Panels reviewing materials intended for racial and ethnic
minority populations must comply with the terms of a and b above.
However, membership of the Program Review Panel may be drawn
predominantly from such racial and ethnic populations.
2. Applicants for CDC assistance will also be required to include
in their applications a letter or memorandum from the State,
territorial, or local education agency concurring with this guidance
and assuring that its provisions will be observed.
C. When a cooperative agreement/grant is awarded and periodically
thereafter, the recipient will:
1. Present for the assessment of the appropriately identified
Program Review Panel(s) established by a State, territorial or local
education agency, copies of written materials, pictorials,
audiovisuals, and marketing, advertising, Web site HIV/AIDS educational
materials, questionnaires, and surveys proposed to be used. The Program
Review Panel(s) shall pay particular attention to ensure that none of
the above materials violate the provisions of sections 2500 and 317P of
the Public Health Service Act.
2. Provide for assessment by the appropriately identified Program
Review Panel(s) established by a State, territorial or local education
agency, the text, scripts, or detailed descriptions for written
materials, pictorials, audiovisuals, and marketing, advertising, and
Web site materials that are under development.
3. Prior to expenditure of funds related to the ultimate program
use of these materials, assure that its project files contain a
statement(s) signed by the chairperson of the appropriately identified
Program Review Panel(s) established by a State or local education
agency, specifying the vote for approval or disapproval for each
proposed item submitted to the panel.
4. Include a certification that accountable State, territorial, or
local education agency officials have independently reviewed written
materials, pictorials, audiovisuals, and marketing, advertising, and
Web site materials for compliance with section 2500 and 317P of the
Public Health Service Act and approved the use of such materials in
their jurisdiction.
5. As required in the notice of grant award, provide to CDC in
regular progress reports, signed statement(s) of the chairperson of the
Program Review Panel(s) specifying the vote for approval or disapproval
for each proposed item that is subject to this guidance.
D. CDC-funded organizations, which are national or regional (multi-
State) in scope, or that plan to distribute materials as described
above to other organizations on a national or regional basis, must
identify a single Program Review Panel to fulfill this requirement.
Those guidelines identified in sections I.A. through I.E. and II.A.
through II.C. outlined above also apply. In addition, such national/
regional panels must include, as a member, an employee of a State or
local education agency and an employee of a State or local health
department.
[FR Doc. 04-13554 Filed 6-15-04; 8:45 am]
BILLING CODE 4163-18-P