TITLE: B-308128, Abstinence Education: Applicability of Section 317P of the Public Health Service Act, October 18, 2006
BNUMBER: B-308128
DATE: October 18, 2006
****************************************************************************************************************
B-308128, Abstinence Education: Applicability of Section 317P of the Public Health Service Act, October 18, 2006

   B-308128

   October 18, 2006

   The Honorable Michael O. Leavitt

   Secretary of Health and Human Services

   Subject: Abstinence Education: Applicability of Section 317P of the Public
   Health Service Act

   Dear Mr. Secretary:

   In responding to a congressional request on federal abstinence education
   grant programs, we identified a legal matter that requires the attention
   of the Department of Health and Human Services (HHS). In this regard,
   section 317P(c)(2) of the Public Health Service Act.[1] requires certain
   educational materials to contain medically accurate information about
   condom effectiveness. HHS believes that this statute does not apply to
   materials prepared and used by recipients of federal abstinence education
   grants. As discussed below, we conclude that this requirement would apply
   to abstinence education materials prepared and used by federal grant
   recipients, depending upon the substantive content of those materials. We
   did not assess any particular abstinence education materials for
   compliance with section 317P(c)(2) and, therefore, reach no conclusions
   regarding statutory violations. However, in light of our conclusion, we
   recommend that HHS reexamine its position and adopt measures to ensure
   that, where applicable, abstinence education materials comply with this
   requirement.

   BACKGROUND

   As you know, HHS supports efforts to provide abstinence education
   primarily through grants to states, local communities, and private
   organizations under three programs. First, under section 510 of the Social
   Security Act,[2] HHS makes formula grants to states for the provision of
   abstinence education, targeting those most likely to have children
   out-of-wedlock. In addition, under section 1110 of the Social Security
   Act,[3] HHS awards community-based grants through a competitive process to
   public and private entities for the purpose of creating an environment
   that supports postponing sexual activity until marriage.[4] Grants may be
   used to support before and after school programs, adult and peer
   mentoring, and parent education groups.[5] Through the adolescent family
   life program established by Title XX of the Public Health Service Act,[6]
   HHS also makes competitive grants to public and private nonprofit
   organizations, including community, school, and faith-based organizations,
   to facilitate abstinence education. The state formula and community-based
   grant programs are administered by the Administration for Children and
   Families (ACF) within HHS and the adolescent family life program is
   administered by the Office of Population Affairs, which is located in the
   Office of the Secretary.

   Section 510(b)(2) of the Social Security Act defines "abstinence
   education" for purposes of the state formula grant program, effectively
   requiring grantees to meet eight criteria;[7] annual appropriations acts
   and program announcements have extended these criteria to the
   community-based and adolescent family life program grants as well.[8]
   Three of these criteria focus on the physical consequences of sexual
   activity, and one explicitly references sexually transmitted diseases.
   Specifically, abstinence education for which federal funds may be provided
   must (1) have as its exclusive purpose teaching the social, psychological,
   and health gains to be realized by abstaining from sexual activity; (2)
   teach that abstinence from sexual activity is the only certain way to
   avoid out-of-wedlock pregnancy, sexually transmitted diseases, and other
   associated health problems; and (3) teach that sexual activity outside of
   the context of marriage is likely to have harmful psychological and
   physical effects. Annual announcements about the three grant programs also
   instruct grantees to incorporate material related to sexually transmitted
   diseases.[9]

   During the course of our congressionally requested work on abstinence
   education, we identified a federal statute relevant to these grants.
   Section 317P of the Public Health Service Act addresses human
   papillomavirus specifically, as well as sexually transmitted diseases
   generally. Section 317P(c)(1) requires the Secretary to prepare and
   distribute educational materials to the public and health care providers
   that include information on human papillomavirus. Among other things, the
   materials are to address modes of transmission and the consequences of
   infection. Subsection (c)(2), which is pertinent to our review, states:

     Educational material under paragraph (1), and all other relevant
     educational and prevention materials prepared and printed from this date
     forward for the public and health care providers by the Secretary
     (including materials prepared through the Food and Drug Administration,
     the Centers for Disease Control and Prevention, and the Health Resources
     and Services Administration), or by contractors, grantees, or subgrantees
     thereof, that are specifically designed to address [sexually transmitted
     diseases] including [human papillomavirus] 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. Such requirement only applies to materials mass
     produced for the public and health care providers, and not to routine
     communications.

   By letter of May 26, 2006, we solicited the views of HHS's General Counsel
   on the applicability of section 317P(c)(2) to the three abstinence
   education grant programs described above. In a response dated July 26,
   2006, the Assistant Secretary for Children and Families advised that the
   statute does not apply, given the purpose of abstinence education programs
   and the populations targeted by program grantees.

   DISCUSSION

   By its own terms, section 317P(c)(2) is quite broad. It applies not only
   to the educational material on human papillomavirus described in the first
   paragraph of section 317P(c), but to "all other relevant educational and
   prevention materials" prepared by the Secretary of HHS. In addition, it
   extends to materials prepared by contractors, grantees, and subgrantees
   and to material pertaining to sexually transmitted diseases including, and
   thus not limited to, human papillomavirus. However, the provision contains
   a significant limitation: it extends only to materials that are
   "specifically designed to address" sexually transmitted diseases. The
   statute does not define this phrase and the legislative history provides
   no guidance as to its meaning.[10]

   HHS has not issued a regulation or published guidance interpreting section
   317P(c)(2). In addition, we found no references to that provision, which
   was enacted in December 2000, in grant application guidance or program
   announcements on abstinence education programs dating from 2001.[11]
   Notably, HHS included a reference to section 317P(c)(2) in proposed
   content guidelines for AIDS-related materials issued in 2004.[12] However,
   the proposed guidelines stated only that "When HIV materials include a
   discussion of condoms, the materials must comply with Section 317P . . .
   ."[13] This statement could be read to suggest that the statute only
   applies to materials designed to address sexually transmitted diseases if,
   and only if, the materials discuss condom use.

   In our view, the interpretation of section 317P(c)(2) reflected in the
   proposed guidelines is not consistent with the statute. Neither the
   language nor the structure of section 317P(c)(2) supports an
   interpretation that the need to provide medically accurate information on
   condom effectiveness arises only where the materials include information
   on condoms.[14] The provision does not state that educational materials
   prepared by the Secretary or by grantees that are specifically designed to
   address condom use shall contain medically accurate information regarding
   the effectiveness of condoms in preventing sexually transmitted diseases.
   To the contrary, it provides that materials that are specifically designed
   to address sexually transmitted diseases shall contain medically accurate
   information on condom effectiveness. The syntax of the sentence and
   Congress's choice of the mandatory "shall"[15] clearly indicate that
   materials specifically designed to address sexually transmitted diseases
   are to contain medically accurate information as to the effectiveness of
   condom use in preventing transmission of such diseases. Therefore, the
   Secretary, grantees, and others to whom the statute applies are required
   to include information on condom effectiveness, and that information must
   be medically accurate, in materials otherwise meeting the statutory
   criteria.

   In response to our inquiries, the Assistant Secretary for Children and
   Families stated that materials prepared by its abstinence education
   grantees do not fall within the scope of section 317P(c)(2). He explained
   that the primary purpose of these programs is not to address sexually
   transmitted diseases and that, while grantees may address issues related
   to sexually transmitted diseases in communicating the importance of
   abstinence, they are to address these issues only within the broader
   context of abstinence education, as defined by law. Moreover, he pointed
   out that a variety of organizations receive abstinence education grants
   and materials are produced for different target populations.

   The Assistant Secretary's response is not persuasive. Both the statutory
   definition of abstinence education and grant program materials distributed
   by HHS suggest that section 317P(c)(2) would apply to materials prepared
   and used by recipients of abstinence education grants, depending upon the
   substantive content of those materials. As discussed above, the governing
   statutory provision and program announcements incorporate multiple
   references to the physical consequences of sexual activity, specifically
   requiring information on sexually transmitted diseases to be an integral
   part of abstinence education programs. Notably, the 2006 program
   announcement for the community-based abstinence education program
   instructs grantees to develop curricula around themes and further
   instructs them to incorporate material around the subtheme of sexually
   transmitted diseases. In this regard, it offers several illustrations of
   appropriate program content and endorses the use of disease-specific
   information. It states that abstinence education programs may contain
   information on the limitations of contraception to consistently prevent
   sexually transmitted diseases, as well as information on the epidemiology
   of sexually transmitted diseases in the United States.[16] This
   information could include infection rates and modes of transmission for
   sexually transmitted diseases.[17] Therefore, grantees could incorporate
   sufficiently specific information about these diseases to lead to the
   conclusion that the materials were "specifically designed to address"
   sexually transmitted diseases, whether or not they were primarily designed
   to do so.[18]

   The content of a student workbook commonly used by abstinence education
   grantees further suggests that section 317P(c)(2) may apply to federally
   funded abstinence education materials.[19] The workbook contains eight
   chapters, each of which focuses on a dimension of abstinence. One chapter
   is dedicated to the topic of sexually transmitted diseases. Among other
   things, the chapter provides information on several sexually transmitted
   diseases, including human papillomavirus, in a series of brief paragraphs.
   For example, it explains that the human immunodeficiency virus or HIV
   affects the body's T-4 cells, which are central to the immune system and
   necessary for the body to fight diseases. It also points out that there is
   no cure for HIV. Although the chapter contains general statements about
   condom effectiveness, it does not contain information about the
   effectiveness or lack of effectiveness of condoms in preventing HIV or the
   other diseases it describes.

   The Assistant Secretary's view that section 317P(c)(2) is inapplicable
   since ACF grants are made to a variety of grantees and materials are
   prepared for different target populations is also not persuasive. We do
   not believe that the applicability of section 317P(c)(2) turns on whether
   materials are prepared for all members of the public, as the Assistant
   Secretary suggests. As a general matter, abstinence education programs
   target broad segments of the population, namely, preadolescents and
   adolescents. While grantees may not prepare identical materials for all
   recipients of program services, they nonetheless may produce educational
   materials in large quantities for those members of the public for whom the
   materials are appropriate. We also note that the 2004 proposed content
   guidelines for AIDS-related materials did not reflect the Assistant
   Secretary's apparent view that section 317P(c)(2) only applies to
   materials distributed to all members of the public. Those proposed
   guidelines were designed to apply to materials used by school-based and
   other assistance programs rather than materials distributed to all members
   of the public.

   CONCLUSION

   The statutory requirement to include medically accurate information on
   condom effectiveness would apply to abstinence education materials
   prepared and used by federal grant recipients, depending upon the
   substantive content of those materials. While general references to
   sexually transmitted diseases would appear insufficient to trigger the
   application of section 317P(c)(2) of the Public Health Service Act, the
   inclusion of more detailed information as an essential element of the
   materials' design would require the incorporation of medically accurate
   information on condom effectiveness. As stated above, we did not assess
   any particular materials for compliance with section 317P(c)(2) and,
   therefore, reach no conclusions regarding statutory violations. However,
   in light of our conclusion, we recommend that HHS reexamine its position
   and adopt measures to ensure that, where applicable, abstinence education
   materials comply with this requirement.

   Sincerely yours,

   Gary L. Kepplinger
   General Counsel

   cc: The Honorable Henry A. Waxman
       Ranking Minority Member
       Committee on Government Reform
       House of Representatives

       The Honorable Pete Stark
       Ranking Minority Member
       Subcommittee on Health
       Committee on Ways and Means
       House of Representatives

       The Honorable Sherrod Brown
       Ranking Minority Member
       Subcommittee on Health
       Committee on Energy and Commerce
       House of Representatives

       The Honorable Barbara Boxer
       The Honorable Maria Cantwell
       The Honorable Tom Coburn
       The Honorable Richard J. Durbin
       The Honorable Russell D. Feingold
       The Honorable Dianne Feinstein
       The Honorable Tom Harkin
       The Honorable James M. Jeffords
       The Honorable Edward M. Kennedy
       The Honorable Frank R. Lautenberg
       The Honorable Patrick Leahy
       The Honorable Patty Murray
       United States Senate

       The Honorable Howard L. Berman
       The Honorable Lois Capps
       The Honorable Jay Inslee
       The Honorable Barbara Lee
       The Honorable Nita M. Lowey
       The Honorable Betty McCollum
       House of Representatives

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

   [1] 42 U.S.C. sect. 247b-17(c)(2) (2000).

   [2] 42 U.S.C. sect. 710 (2000 & Supp. III 2003).

   [3] 42 U.S.C. sect. 1310 (2000 & Supp. IV 2004). This section authorizes
   the Secretary to make grants to states, local governments, and other
   entities for a wide range of demonstration projects.

   [4] Announcement, Department of Health and Human Services, Administration
   for Children and Families, Community-Based Abstinence Education Program,
   Funding Opportunities FY 2006, p. 3.

   [5] Id.

   [6] 42 U.S.C. sect.sect. 300z et seq. (2000). Title XX authorizes the
   Secretary to make grants for demonstration projects to help communities
   provide appropriate care and prevention services in easily accessible
   locations. The term "prevention services" means necessary services to
   prevent adolescent sexual relations. 42 U.S.C. sect. 300z-1(a)(8).

   [7] 42 U.S.C. sect. 710(b)(2)(A)-(H).

   [8] See, e.g., Departments of Labor, Health and Human Services, and
   Education, and Related Agencies Appropriations Act, 2006, Pub. L. No.
   109-149, 119 Stat. 2833, 2855-56 (providing funds for community-based and
   adolescent family life program abstinence education grants consistent with
   the criteria at section 510(b)(2) and, with respect to community-based
   grants, further providing for grantees not to provide any other education
   regarding sexual conduct, except to the extent that health information or
   services are legally required to be provided and are provided in a setting
   different from abstinence education). See also Notice,  Department of
   Health and Human Services, Office of the Secretary, Availability of Funds
   for Adolescent Family Life Demonstration Projects, 69 Fed. Reg. 17,888-89
   (April 5, 2004); Announcement, Department of Health and Human Services,
   Administration for Children and Families, Community-Based Abstinence
   Education Program, Funding Opportunities FY 2006, p. 2.

   [9] See, e.g., Announcement, Department of Health and Human Services,
   Administration for Children and Families, Community-Based Abstinence
   Education Program, Funding Opportunities FY 2006, pp. 2, 7-8;
   Announcement, Department of Health and Human Services, Administration for
   Children and Families, Section 510 Abstinence Education Program, FY 2006
   Program Announcement, p. 9; Notice, Department of Health and Human
   Services, Office of the Secretary, Availability of Funds for Adolescent
   Family Life Demonstration Projects, 69 Fed. Reg. 17,888-89 (April 5,
   2004).

   [10] The sponsor of the provision was particularly concerned that women
   had been misled to believe that condoms were effective in preventing human
   papillomavirus and had suffered serious health consequences as a result.
   146 Cong. Rec. H9844 (daily ed. Oct. 12, 2000) (statement of
   Representative Coburn). See also 146 Cong. Rec. H2692-93 (daily ed. May 9,
   2000) (statement of Representative Coburn). This provision was initially
   included as an amendment to a bill that was subsequently enacted as the
   Breast and Cervical Cancer Prevention and Treatment Act of 2000. A similar
   provision had been contained in an earlier bill introduced by
   Representative Coburn. See H.R. 3248, 106^th Cong. sect. 2 (1999). The
   provision was ultimately enacted as part of the Consolidated
   Appropriations Act, 2001. See Pub. L. No. 106-554, app. A, sect. 516, 114
   Stat. 2763, 2763A-72 to 73 (Dec. 21, 2000).

   [11] For the state and community-based programs, we reviewed the annual
   announcements for 2001 through 2006. For the adolescent family life
   program, we reviewed announcements for 2002 and 2004, the latest years for
   which they were published.

   [12] See Notice, 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, 69 Fed. Reg. 33,824 (June 16,
   2004); Notice, 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, 69 Fed. Reg.
   33,826 (June 16, 2004).

   [13] 69 Fed. Reg. at 33,825 and 33,828.

   [14] See U.S. National Bank of Oregon v. Independent Ins. Agents of
   America, 508 U.S. 439, 455 (1993) ("Statutory construction `is a holistic
   endeavor' . . . and, at a minimum, must account for a statute's full text,
   language as well as punctuation, structure, and subject matter.").

   [15] See, e.g., United States v. Booker, 543 U.S. 220, 233-34 (2005);
   National Railroad Passenger Corp. v. Morgan, 536 U.S. 101, 109 (2002).

   [16] Announcement, Department of Health and Human Services, Administration
   for Children and Families, Community-Based Abstinence Education Program,
   Funding Opportunities FY 2006, p. 8.

   [17] Id.

   [18] Language regarding abstinence education programs in annual
   appropriations acts does not make section 317P inapplicable to abstinence
   education materials. The language simply reiterates that funds made
   available are for abstinence-only education, rather than for educational
   efforts concerning other approaches to sexual conduct. The 2006 program
   announcement for the community-based program supports this reading,
   providing that abstinence education grantees may not promote, endorse,
   distribute, or demonstrate the use of contraception, although they may
   provide information on contraceptives as it supports a message of
   abstinence. Id. at 5-6.

   [19] Abstinence education curricula may include materials used directly by
   students.