Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Controlled Correspondence Related to Generic Drug Development

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

DATES:

Fax written comments on the collection of information by December 12, 2019.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0797. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Controlled Correspondence Related to Generic Drug Development

OMB Control No. 0910-0797—Revision

This information collection supports implementation of the Generic Drug User Fee Amendments (GDUFA) of the FDA Reauthorization Act of 2017 (Pub. L. 115-52, Title III). As established in the “Reauthorization Performance Goals And Program Enhancements Fiscal Years 2018-2022 Letter” (“The GDUFA II Commitment Letter”) under GDUFA, certain goals have been identified with regard to controlled correspondence relating to generic drug development. The GDUFA II Commitment Letter includes details of our commitment to respond to questions submitted as controlled correspondence within certain timeframes. The GDUFA II Commitment Letter also includes details regarding our commitment to respond to requests to clarify FDA ambiguities in a controlled correspondence response within certain timeframes.

To support these program goals, we developed the associated guidance entitled “Controlled Correspondence Related to Generic Drug Development.” The guidance is intended to facilitate our prompt consideration of controlled correspondence and to assist in meeting the prescribed GDUFA II performance goals and timeframes. Specifically, the guidance provides procedural instruction, including recommendations that the following information be included in controlled correspondence submitted to FDA and requests to clarify FDA response to controlled correspondence:

• Name, title, address, phone number, and entity of the person submitting the inquiry;
• a letter of authorization, if applicable;
• the FDA-assigned control number and submission date of any previous, related controlled correspondence that was accepted for substantial review and response, if any, as well as a copy of that previous controlled correspondence and FDA's response, if any;
• the relevant reference listed drug(s), as applicable, including the application number, proprietary (brand) name, manufacturer, active ingredient, dosage form, and strength(s);
• a statement that the controlled correspondence is related to a potential abbreviated new drug application (ANDA) submission to the Office of Generic Drugs and the ANDA number, if applicable;
• a concise statement of the inquiry;
• a recommendation of the appropriate FDA review discipline;
• relevant prior research and supporting materials; and
• the clarifying questions and the corresponding section(s) of FDA's controlled correspondence response on which the requestor is seeking clarification.

In the Federal Register of May 22, 2018 (83 FR 23692), we published a 60-day notice under the PRA requesting public comment on the proposed collection of information. No comments were received in response to the PRA notice. Separately, in the Federal Register of November 3, 2017 (82 FR 51277), we announced the availability of a revised draft version of the associated guidance. Because the guidance is currently being revised to reflect 2018 through 2022 GDUFA reauthorization goals, we are revising the supporting information collection request.

The guidance is being issued consistent with FDA's good guidance practice regulation (21 CFR part 10.115), we intend no changes to the information collection elements recommended, and have not modified the burden estimate we ascribe to the related activities.

We therefore estimate the burden of the information collection as follows:

We base our estimate on a review of Agency data of fiscal year submissions for 2014, 2015, and 2016, which reflects an increase in submissions that we attribute to an increase in generic drug development. Accordingly, we estimate 390 generic drug manufacturers and related industry (e.g., contract research organizations conducting bioanalytical or bioequivalence clinical trials) or their representatives will each submit an average of 3.8 inquiries annually for a total of 1,496 inquiries [1,496 ÷ 390 = 3.8]. Information submitted with each inquiry varies widely in content, depending on the complexity of the request. Inquiries that are defined as controlled correspondence may range from a simple inquiry on generic drug labeling to a more complex inquiry for a formulation assessment for a specific proposed generic drug product. As a result, these inquiries can vary between 1 and 10 burden hours.

Because the content of inquiries considered controlled correspondence is widely varied, we are providing an average burden hour for each inquiry. We estimate that it will take an average of 5 hours per inquiry for industry to gather necessary information, prepare the request, and submit the request to FDA. As a result, we estimate that it will take an average of 7,480 hours annually for industry to prepare and submit inquiries considered controlled correspondence.