Return to nonfamous.com index page

July 01, 2004

Actual text of CDC regulation changes

I'm copying the full text of the proposed changes from the CDC website. It's outrageous.

[Federal Register: June 16, 2004 (Volume 69, Number 115)]
[Notices]
[Page 33823-33826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn04-106]


[[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


[[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 HIVComments@cdc.gov 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

Posted by jay at July 1, 2004 10:52 AM | TrackBack
Comment spammers: see our Unauthorized Advertising Policy and rates
Comments
Post a comment