[Federal Register Volume 69, Number 115 (Wednesday, June 16, 2004)]
[Notices]
[Pages 33824-33826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13553]



[[Page 33823]]

-----------------------------------------------------------------------

Part V





Department of Health and Human Services





-----------------------------------------------------------------------



Centers for Disease Control and Prevention



-----------------------------------------------------------------------



Proposed Revision of Interim HIV Content Guidelines for AIDS-Related 
Materials, Pictorials, Audiovisuals, Questionnaires, Survey 
Instruments, Marketing, Advertising and Web site Materials, and 
Educational Sessions in CDC Regional, State, Territorial, Local, and 
Community Assistance Programs; Notice



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; Notice

  Federal Register / Vol. 69, No. 115 / Wednesday, June 16, 2004 / 
Notices  

[[Page 33824]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Revision of Interim HIV Content Guidelines for AIDS-
Related Materials, Pictorials, Audiovisuals, Questionnaires, Survey 
Instruments, Marketing, Advertising and Web Site Materials, and 
Educational Sessions in CDC Regional, State, Territorial, Local, and 
Community Assistance Programs

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (DHHS).

ACTION: Notice for public comment.

-----------------------------------------------------------------------

SUMMARY: The purpose of this document is to seek public comment on 
proposed revision of the Interim HIV Content Guidelines, entitled 
``Content of AIDS-Related written materials, pictorials, audiovisuals, 
questionnaires, survey instruments, and educational sessions in CDC 
assistance programs'' and to seek public comment on the proposed 
revisions. The HIV Content Guidelines were last revised in 1992. The 
purpose of these revisions 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) improve clarity. Additionally, CDC has developed a separate 
guidance document for school-based assistance programs.

DATES: Submit comments on or before August 16, 2004.

ADDRESSES: Address all comments concerning this notice to HIV Content 
Guidelines Comments, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE., Mailstop E56, Atlanta, Georgia 30333. Comments may 
be e-mailed to [email protected] or faxed to (404) 639-3125.

FOR FURTHER INFORMATION CONTACT: David Hale, Centers for Disease 
Control and Prevention, National Center for HIV, STD, and TB 
Prevention, 1600 Clifton Road, NE., Mailstop E07, Atlanta, Georgia 
30333. Telephone: (404) 639-8008.

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''. These 
guidelines are currently in effect.
    In this notice, CDC is proposing to revise the 1992 HIV Content 
Guidelines. The purpose of these revisions 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) improve clarity. CDC anticipates publishing a Final 
Guidance document within 120 days after the conclusion of the comment 
period. Additionally, CDC has developed a separate guidance document 
for school-based assistance programs.

Summary and Explanation of Revisions for Regional, State, Territorial, 
or Local, and Community Assistance Programs

    The proposed HIV Content Guidelines now:
    (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 health department or 
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 health officials have 
independently reviewed educational 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 health 
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 proposed Guidelines separate the 
guidance into two documents for ease of use and clarity.

[[Page 33825]]

Summary and Explanation of Revision Applicable Only to Community-Based 
Programs

    (8) Require funded community-based organizations to identify a 
program review panel established by a state or local health department. 
While the current Guidelines allow CDC-funded organizations to 
establish their own PRP, they are encouraged to use a PRP established 
by a health department or another CDC-funded organization. The proposed 
Guidelines will no longer permit organizations to establish their own 
PRP. Instead, recipients of HIV/AIDS funds are required to identify a 
PRP established by a state or local health department within their 
state's jurisdiction.

    Dated: June 7, 2004.
James D. Seligman,
Associate Director for Program Support, 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 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 and local health departments, to consider the 
appropriateness of messages designed to communicate with various 
groups. State and local health departments may, if they deem it 
appropriate, establish multiple Program Review Panels to consider the 
appropriateness of messages designed to communicate with various 
groups.
    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 a state or local health department, 
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 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.''

II. Program Review Panel

    Each recipient will be required to identify at least one Program 
Review Panel, established by a state or local health department from 
the jurisdiction of the recipient. 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--these 
questionnaires or survey instruments are limited to use in the 
designated research project). 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) and 
whether 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 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. Applicants for CDC assistance will be required to include in 
their applications the following:
    1. Identification of at least one panel, established by a state or 
local health department, of no less than five persons who represent a 
reasonable cross-section of the jurisdiction in which the program is 
based. 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 d 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

[[Page 33826]]

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. The composition of Program Review Panels must include an 
employee of a state or local health department with appropriate 
expertise in the area under consideration, who is designated by the 
health department to represent the department on the panel.
    d. Panels reviewing materials intended for racial and ethnic 
minority populations must comply with the terms of a-c above. However, 
membership of the Program Review Panel may be drawn predominantly from 
such racial and ethnic populations.
    2. A letter or memorandum to the applicant from the state or local 
health department, which includes:
    a. Concurrence with this guidance and assurance that its provisions 
will be observed.
    b. The identity of members of the Program Review Panel, including 
their names, occupations, and any organizational affiliations that were 
considered in their selection for the panel.
    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 or local health 
department, 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 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 or local health department, 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 health 
department, specifying the vote for approval or disapproval for each 
proposed item submitted to the panel.
    4. Include a certification that accountable state or local health 
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 for 
directly and indirectly funded community-based organizations.
    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.D. 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 health department.

[FR Doc. 04-13553 Filed 6-15-04; 8:45 am]
BILLING CODE 4163-18-P