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Food and Drug Administration, HHS.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on controlled correspondence related to generic drug development.
Submit either electronic or written comments on the collection of information by July 23, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Submit electronic comments in the following way:
Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2018-D-1592 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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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.
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Start Supplemental Information
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the Start Printed Page 23693information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
OMB Control Number 0910-0797—Extension
FDA has agreed to specific program enhancements and performance goals specified in the Generic Drug User Fee Act Reauthorization (GDUFA II) Commitment Letter. One of the performance goals applies to controlled correspondence related to generic drug development. The GDUFA II Commitment Letter includes details on FDA's commitment to respond to questions submitted as controlled correspondence within certain timeframes. To support these program goals, we have developed the guidance entitled “Controlled Correspondence Related to Generic Drug Development.” The guidance is intended to facilitate FDA's prompt consideration of controlled correspondence and to assist in meeting the prescribed timeframes by providing procedural recommendations to include the following information in the inquiry: (1) Name, title, address, phone number, and entity of the person submitting the inquiry; (2) a letter of authorization, if applicable; (3) 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; (4) the relevant reference listed drug(s), as applicable, including the application number, proprietary (brand) name, manufacturer, active ingredient, dosage form, and strength(s); (5) 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; (6) a concise statement of the inquiry; (7) a recommendation of the appropriate FDA review discipline; and (8) relevant prior research and supporting materials.
The GDUFA II Commitment Letter also includes details on FDA's commitment to respond to requests to clarify ambiguities in FDA's controlled correspondence response within certain timeframes. To facilitate FDA's prompt consideration of the request and to assist in meeting the prescribed timeframes, the guidance recommends including the following information in the inquiry: (1) Name, title, address, phone number, and entity of the person submitting the inquiry; (2) a letter of authorization, if applicable; (3) the FDA-assigned control number, submission date of the controlled correspondence on which the requestor is seeking clarification, a copy of that previous controlled correspondence, and FDA's response to the controlled correspondence; and (4) the clarifying questions and the corresponding section(s) of FDA's controlled correspondence response on which the requestor is seeking clarification. This information collection supports this Agency guidance.
We estimate the burden of the information collection as follows:
Table 1—Estimated Annual Reporting Burden 1
|Submission of controlled correspondence||Number of respondents||Number of responses per
respondent||Total annual responses||Average burden per
|Generic drug manufacturers, related industry, and representatives||390||3.8||1,496||5||7,480|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
This is the first extension of the information collection and 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 total hours annually for industry to prepare and submit inquiries considered controlled correspondence.
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Dated: May 16, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-10856 Filed 5-21-18; 8:45 am]
BILLING CODE 4164-01-P