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Federal Register / Vol. 72, No.

243 / Wednesday, December 19, 2007 / Rules and Regulations 71785

Rectal Epithelium,’’ Contraception, that these products do not protect with only one partner who is not
62:149–154, 2002. against the transmission of the AIDS infected with HIV and who has no other
20. Phillips, D. M. et al., ‘‘Lubricants virus (HIV) or other STDs, that use of sexual partners or HIV risk factors’’.
Containing N–9 May Enhance Rectal these products can increase vaginal and (3) ‘‘[bullet] use a latex condom
Transmission of HIV and Other STIs,’’ rectal irritation, which may increase the without nonoxynol 9 if you or your sex
Contraception, 70:107–110, 2004. risk of getting the AIDS virus (HIV) from partner has HIV/AIDS, multiple sex
an HIV infected partner, and that the partners, or other HIV risk factors’’.
List of Subjects in 21 CFR Part 201 (4) ‘‘[bullet] ask a health professional
products are not for rectal use.
Drugs, Labeling, Reporting and Consumers should also be warned that if you have questions about your best
recordkeeping requirements. these products should not be used by birth control and STD prevention
■ Therefore, under the Federal Food, persons who have HIV/AIDS or are at methods’’.
Drug, and Cosmetic Act and under high risk for HIV/AIDS. (e) Any drug product subject to this
authority delegated to the Commissioner (b) The labeling of OTC vaginal section that is not labeled as required
of Food and Drugs, 21 CFR part 201 is contraceptive and spermicide drug and that is initially introduced or
amended as follows: products containing nonoxynol 9 as the initially delivered for introduction into
active ingredient, whether subject to the interstate commerce after June 19, 2008,
PART 201—LABELING ongoing OTC drug review or an is misbranded under section 502 of the
approved drug application, must Federal Food, Drug, and Cosmetic Act
■ 1. The authority citation for 21 CFR contain the following warnings under (the act) (21 U.S.C. 352), is a new drug
part 201 continues to read as follows: the heading ‘‘Warnings,’’ in accordance under section 505 of the act (21 U.S.C.
Authority: 21 U.S.C. 321, 331, 351, 352, with 21 CFR 201.66. 355), and is subject to regulatory action.
353, 355, 358, 360, 360b, 360gg–360ss, 371, (1) ‘‘[bullet] For vaginal use only Dated: December 10, 2007.
374, 379e; 42 U.S.C. 216, 241, 262, 264. [bullet] Not for rectal (anal) use’’ [both Jeffrey Shuren,
■ 2. Section 201.66 is amended by warnings in bold type].
Assistant Commissioner for Policy.
adding paragraph (c)(5)(ii)(H) to read as (2) ‘‘Sexually transmitted diseases
(STDs) alert [in bold type]: This product [FR Doc. 07–6111 Filed 12–18–07; 8:45 am]
does not [word ‘‘not’’ in bold type] BILLING CODE 4160–01–S
§ 201.66 Format and content requirements protect against HIV/AIDS or other STDs
for over-the-counter (OTC) drug product and may increase the risk of getting HIV
from an infected partner’’.
* * * * * (3) ‘‘Do not use’’ [in bold type] if you
(c) * * * or your sex partner has HIV/AIDS. If 22 CFR Part 124
(5) * * * you do not know if you or your sex [Public Notice 6031]
(ii) * * * partner is infected, choose another form
(H) Sexually transmitted diseases of birth control’’. Amendment to the International Traffic
(STDs) warning for vaginal (4) ‘‘When using this product [in bold in Arms Regulations: Regarding Dual
contraceptive and spermicide drug type] [optional, bullet] you may get and Third Country Nationals
products containing nonoxynol 9 set vaginal irritation (burning, itching, or a
forth in § 201.325(b)(2). This warning rash)’’. AGENCY: Department of State.
shall follow the subheading ‘‘Sexually (5) ‘‘Stop use and ask a doctor if [in ACTION: Final rule.
transmitted diseases (STDs) alert:’’ bold type] [optional, bullet] you or your
SUMMARY: The Department of State is
* * * * * partner get burning, itching, a rash, or
amending the text of the International
■ 3. Section 201.325 is added to subpart other irritation of the vagina or penis’’.
(c) The labeling of this product states Traffic in Arms Regulations (ITAR) to
G to read as follows: allow access to defense articles and
under the ‘‘Other information’’ section
§ 201.325 Over-the-counter drugs for of the Drug Facts labeling in accordance services for dual and third country
vaginal contraceptive and spermicide use with § 201.66(c)(7), ‘‘[bullet] when used nationals of certain countries through
containing nonoxynol 9 as the active correctly every time you have sex, latex revisions in procedures for technical
ingredient; required warnings and labeling condoms greatly reduce, but do not assistance agreements and
eliminate, the risk of catching or manufacturing licensing agreements.
(a) Studies indicate that use of vaginal spreading HIV, the virus that causes This regulatory change will reduce the
contraceptive drug products containing AIDS. burden on exporters of defense articles
nonoxynol 9 does not protect against (d) The labeling of this product and on foreign parties to the agreements
infection from the human includes the following statements either by reducing the number of individual
immunodeficiency virus (HIV), the virus on the outside container or wrapper of Non Disclosure Agreements (NDA’s)
that causes acquired immunodeficiency the retail package, under the ‘‘Other which must be executed and maintained
syndrome (AIDS), or against the information’’ section of the Drug Facts on file.
transmission of other sexually labeling in accordance with DATES: Effective Date: This rule is
transmitted diseases (STDs). Studies § 201.66(c)(7), or in a package insert: effective December 19, 2007.
also indicate that use of vaginal (1) ‘‘[bullet] studies have raised safety ADDRESSES: Interested parties may
contraceptive drug products containing concerns that products containing the submit comments at any time by any of
nonoxynol 9 can increase vaginal spermicide nonoxynol 9 can irritate the the following methods:
irritation, such as the disruption of the vagina and rectum. Sometimes this • E-mail:
vaginal epithelium, and also can cause irritation has no symptoms. This DDTCResponseTeam@state.gov with an
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epithelial disruption when used in the irritation may increase the risk of getting appropriate subject line.
rectum. These effects may increase the HIV/AIDS from an infected partner’’. • Mail: Department of State,
risk of transmission of the AIDS virus (2) ‘‘[bullet] you can use nonoxynol 9 Directorate of Defense Trade Controls,
(HIV) from an infected partner. for birth control with or without a Office of Defense Trade Controls Policy,
Therefore, consumers should be warned diaphragm or condom if you have sex ATTN: Regulatory change, ITAR

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71786 Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Rules and Regulations

§§ 124.12 and 124.16, SA–1, 12th Floor, are nationals exclusively from countries List of Subjects in 22 CFR Part 124
Washington, DC 20522–0112. that are members of the North Atlantic
• Hand delivery or Courier (regular Treaty Organization (NATO), the Arms and Munitions, Exports,
work hours only): Department of State European Union (EU), Australia, Japan, Technical Assistance.
Directorate of Defense Trade Controls, New Zealand, and Switzerland. These ■ Accordingly, for the reasons set forth
Office of Defense Trade Controls Policy, procedural changes would also apply to above, Title 22, Chapter I, Subchapter
ATTENTION: Regulatory Change, ITAR employees of sub-licensees authorized M, part 124 is amended as follows:
§§ 124.12 and 124.16, SA–1, 12th Floor, under the agreement. Execution of
2401 E Street, NW., Washington, DC NDAs by individuals who are third PART 124—AGREEMENTS, OFF-
20037. country or dual nationals meeting the SHORE PROCUREMENT AND OTHER
Persons with access to the Internet preceding criteria would not be DEFENSE SERVICES
may also view this notice by going to required. These changes are being
the regulations.gov Web site at http:// implemented by an additional clause in ■ 1. The authority citation for part 124
regulations.gov/index.cfm. the transmittal letter required under continues to read as follows:
FOR FURTHER INFORMATION CONTACT: § 124.12 (c) whereby the applicant will Authority: Sec. 2, 38, and 71, Pub. L. 90–
Acting Director Terry Davis, Office of request retransfer of defense articles and 629, 90 Stat. 744 (22 U.S.C. 2752, 2778,
Defense Trade Controls Licensing, services to third country/dual nationals 2797); E.O. 11958, 42 FR 4311; 3 CFR 1977,
Department of State, Telephone (202) from these countries under the authority Comp. p. 79; 22 U.S.C. 2651a; 22 U.S.C. 2776;
of a new ITAR § 124.16 entitled Pub L. 105–261.
663–2739 or Fax (202) 663–3866, E-mail
DDTCResponseTeam@state.gov. ATTN: ‘‘Special Retransfer Authorizations for ■ 2. Section 124.12 is amended by
Regulatory Change, ITAR §§ 124.12 and Unclassified Technical Data and adding a new paragraph (a)(10) to read
124.16. Defense Services to Member States of as follows:
Department of State, Directorate of Australia, Japan, New Zealand, and § 124.12 Required information in letters of
Defense Trade Controls (DDTC) has Switzerland.’’ transmittal.
recently completed a review of licensing Regulatory Analysis and Notices (a) * * *
requirements for technical assistance (10) A statement specifying whether
and manufacturing license agreements Administrative Procedure Act
the applicant is requesting retransfer of
(TAAs/MLAs) under Part 124 of the This amendment involves a foreign defense articles and defense services
ITAR. The Department has long affairs function of the United States and, pursuant to § 124.16 of this subchapter.
followed a procedure to license to all therefore, is not subject to the * * * * *
countries of ultimate destination, procedures required by 5 U.S.C. 553 and
including to nationals of countries other 554. ■ 3. Section 124.16 is added to read as
than the country to which the items are follows:
Regulatory Flexibility Act
to be exported under the TAA/MLA. In § 124.16 Special Retransfer Authorizations
particular, § 124.8(5) precludes any This rule does not require analysis for Unclassified Technical Data and
retransfer of defense articles (hardware under the Regulatory Flexibility Act. Defense Services to Member States of
or technical data) or defense services Unfunded Mandates Act of 1995 NATO and the European Union, Australia,
pursuant to an approved TAA/MLA to Japan, New Zealand, and Switzerland.
third countries or nationals of third This rule does not require analysis
under the Unfunded Mandates Reform The provisions of § 124.8(5) of this
countries unless specifically authorized subchapter notwithstanding, pursuant
in the agreement or for which prior Act.
to this subsection the Department may
written approval has been granted by Small Business Regulatory Enforcement approve access to unclassified defense
the Department. For export control Fairness Act of 1996 articles exported in furtherance of or
purposes, DDTC has considered a third produced as a result of a TAA/MLA,
This amendment has been found not
country national to be an individual and retransfer of technical data and
to be a major rule within the meaning
from a country other than the country defense services to individuals who are
of the Small Business Regulatory
which is the foreign signatory to the third country/dual national employees
Enforcement Fairness Act of 1996.
agreement. A third country national of the foreign signatory or its approved
may also be a dual national if he holds Executive Orders 12372 and 13132 sub-licensees provided they are
nationality from more than one country. It is determined that this rule does not nationals exclusively of countries that
In addition to citizenship, DDTC have sufficient federalism implications are members of NATO the European
considers country of birth a factor in to warrant application of the Union, Australia, Japan, New Zealand,
determining nationality. consultation provisions of Executive and Switzerland and their employer is
Current procedures require that third Orders 12372 and 13132. a signatory to the agreement or has
country/dual nationals authorized executed a Non Disclosure Agreement.
under TAA/MLA’s execute Non Executive Order 12866
The retransfer must take place
Disclosure Agreements (NDAs) before This amendment is exempt from the completely within the physical
they receive access to defense articles or review under Executive Order 12866, territories of these countries or the
defense services. The changes to Part but has been reviewed internally by the United States. Permanent retransfer of
124 would revise these procedures to Department of State to ensure hardware is not authorized.
permit the U.S. applicant to request consistency with the purposes thereof.
further release of technical data and Dated: November 27, 2007.
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defense services and access to defense Paperwork Reduction Act John C. Rood,
articles exported pursuant to or This rule does not impose any new Acting Under Secretary for Arms Control and
produced as a result of the TAA/MLA reporting or recordkeeping requirements International Security, Department of State.
to third country/dual national subject to the Paperwork Reduction Act, [FR Doc. E7–24651 Filed 12–18–07; 8:45 am]
employees of the foreign signatory who 44 U.S.C. Chapter 35. BILLING CODE 4710–25–P

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