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Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices I. General Description of the Committee Duties The Tobacco Products Scientific Advisory Committee the Committee advises the Commissioner of FDA the Commissioner or designee in discharging responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates behavior, dependence, and health issues, among others, relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner.

Dated: September 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

II. Criteria for Voting Members
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

The Committee shall consist of 12
members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of science, medicine, medical ethics, or technology involving the manufacture, evaluation, or use of tobacco products.
Almost all non-Federal members of this committee serve as Special Government Employees. The Committee shall include nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members shall be scientists, physicians, dentists, or healthcare professionals practicing in the areas of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, epidemiology, behavioral health, or any other relevant specialty. One member shall be an officer or employee of a state or local government or of the Federal Government. The final voting member shall be a representative of the general public. Members will be invited to serve for terms of up to 4 years.
III. Nomination Procedures
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contracts to permit evaluation of possible sources of conflicts of interest.
This notice is issued under the Federal Advisory Committee Act 5
U.S.C. app. 2 and 21 CFR part 14, relating to advisory committees.

Any interested person may nominate one or more qualified individuals for membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current, complete resume or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal see ADDRESSES.
Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or
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Food and Drug Administration Docket No. FDA2019N5464

Center for Drug Evaluation and Research Office of New Drugs Novel Excipient Review Pilot Program AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administrations FDA Center for Drug Evaluation and Research CDER is announcing a Novel Excipient Review Pilot Program Pilot Program. The Pilot Program is voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations.
The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.
DATES: FDA is seeking initial proposals for the voluntary Novel Excipient Review Pilot Program through December 7, 2021.
FOR FURTHER INFORMATION CONTACT:
Felecia Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, Novel-ExcipientProgram@fda.hhs.gov, 3017969590.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background Excipient manufacturers and drug developers have cited product development challenges related to the use of certain excipients also known as inactive ingredients, including issues related to formulation and stability.
Novel excipients might be able to address some of these issues and provide additional public health benefits, such as enhanced drug bioavailability, more comfortable drug administration, new abuse-deterrent opioid formulations, new routes of drug
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delivery, and facilitation of new technologies. However, drug developers report that they have been hesitant to use novel excipients in drug development programs due to the uncertainty surrounding their acceptability.
To address these issues, FDA issued a request for information in the Federal Register on December 5, 2019 84 FR
66669, seeking comment on a potential pilot program for FDA review of novel excipients. FDA received several comments to the public docket on these issues. After considering these comments, CDER has decided to establish this Pilot Program.
A. Scope For purposes of the Pilot Program, an excipient is any ingredient intentionally added to a drug product including a biological drug product that is not intended to exert therapeutic effects at the intended dosage, although it may improve product delivery see FDA
guidance for industry entitled Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients Ref.1. Examples of excipients may include fillers, extenders, diluents, surfactants, solvents, emulsifiers, preservatives, flavors, absorption enhancers, modified release matrices, and coloring agents.
Also, for purposes of this Pilot Program, a novel excipient is any excipient that is not fully supported by existing safety data with respect to the currently proposed level of exposure, duration of exposure, or route of administration Ref. 1. This parallels the definition of new excipients defined in Ref. 1.
CDER proposes a more limited scope for this Pilot Program. The Pilot Program will initially be available for novel excipients that 1 have not been previously used in FDA-approved drug products, and 2 do not have an established use in food. CDER
recognizes that there may be novel excipients not meeting this scope that may also address product development challenges or provide public health benefits. However, because of the limited scope of the initial phase of the Pilot Program described further below, CDER will not be able to consider submissions for all kinds of novel excipients. CDER may expand the scope of the Pilot Program in the future depending on its success and as resources allow.
The Pilot Program is voluntary.
Existing processes for developing excipients for use in drug and biological products continue to be available.

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