[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1512 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 1512

  To allow women greater access to a wider range of self-administered 
contraceptives approved under the Federal Food, Drug, and Cosmetic Act.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2023

   Ms. Mace introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To allow women greater access to a wider range of self-administered 
contraceptives approved under the Federal Food, Drug, and Cosmetic Act.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Greater Access to Contraceptive 
Options Act''.

SEC. 2. APPLICATIONS FOR NON-PRESCRIPTION CONTRACEPTIVE METHODS.

    (a) Priority Review of Application.--The Secretary of Health and 
Human Services (referred to in this section as the ``Secretary'') shall 
give priority review to any supplemental application submitted under 
section 505(b), 510(k), or 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(b), 360, 360e) for a self-administered contraceptive 
method to be marketed without being subject to section 503(b)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) or treated 
as a prescription device.
    (b) Fee Waiver.--The Secretary shall waive the fee under section 
736(a)(1) or 738(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(a)(1); 379j(a)(2)) (as applicable) with respect to a 
supplemental application that receives priority review under subsection 
(a).
    (c) Applicability.--This section applies with respect to a 
supplemental application described in subsection (a) that--
            (1) is submitted before the date of enactment of this Act 
        and remains pending as of such date of enactment; or
            (2) is submitted after such date of enactment.
    (d) Self-Administered Contraceptive Method Defined.--In this Act, 
the term ``self-administered contraceptive method'' means a drug or 
device (as those terms are defined in section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321)) or combination product approved 
for use under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
et seq.) as a method of contraception that is administered without the 
intervention of a health care professional, including the birth control 
pill, patch, vaginal ring, or injection, such as depot 
medroxyprogesterone acetate.
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