Skip to main content
HR 3742 113th Congress House

Antibiotic Development to Advance Patient Treatment Act of 2013

Official title: To provide for approval of certain drugs and biological products indicated for use in a limited population of patients in order to address increases in bacteri… Show full official titleShow less

Official title: To provide for approval of certain drugs and biological products indicated for use in a limited population of patients in order to address increases in bacterial and fungal resistance to drugs and biological products, and for other purposes.

Introduced: November 20, 2014 See on congress.gov
Health Administrative law and regulatory proceduresAdministrative remediesConsumer affairsDepartment of Health and Human Services
More subjectsShow fewer subjects
Drug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth information and medical recordsInfectious and parasitic diseasesLicensing and registrationsMedical researchPrescription drugs
This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 13, 2013
Referred to the Subcommittee on Health.
Dec 12, 2013
Referred to the House Committee on Energy and Commerce.
Dec 12, 2013
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action December 13, 2013

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013. 113th Congress. Open America. https://openamerica.io/bill/113-HR-3742/
MLA
"H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-3742/.
Bluebook (legal)
H.R. 3742, 113th Cong. (2026), https://openamerica.io/bill/113-HR-3742/.
Markdown link
[H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013](https://openamerica.io/bill/113-HR-3742/)
Report a problem