2020-20619. Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Drug Product Manufacturing, Processing, and Packing Facilities

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of drug product manufacturing, processing, and packing facilities.

DATES:

Submit either electronic or written comments on the collection of information by November 17, 2020.

ADDRESSES:

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 November 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 17, 2020. 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.

Electronic Submissions

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”).

Written/Paper Submissions

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-2020-N-1657 for “Survey of Drug Product Manufacturing, Processing and Packing Facilities.” 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, 240-402-7500.

• 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.govinfo.gov/​content/​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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), 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 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 information 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.

Survey of Drug Product Manufacturing, Processing and Packing Facilities—21 CFR parts 210 and 211

OMB Control Number 0910-NEW

FDA has the responsibility to regulate the safety, as well as the efficacy and quality, of drugs in the United States. Under the Food and Drug Administration Safety and Innovation Act (FDASIA) enacted in 2012, the term current good manufacturing practice (CGMP) includes the implementation of oversight and controls over the manufacturing, processing, and packing of drugs to ensure quality, including managing the risk of, and establishing the safety of, raw materials used in the manufacture of drugs. The safety and availability of drugs can be affected by raw material suppliers, the material supply chain, and the facility's controls over raw material quality. Risk management enables manufacturers to make proper choices and ensure the continued suitability of these materials and supply chains. The Agency needs to better understand how manufacturers, processors, and packers of drug products approach managing risks related to components, containers, and closures as well as the supply and distribution chains between the producers of raw materials and drug product manufacturers, processors, and packers. Such information will allow FDA to examine the potential economic impact of changes to regulations that govern the manufacturing, processing, and packing of drugs.

This is a one-time information collection, the primary purpose of which is to collect industry-wide data on how facilities that manufacture, process, and pack drug products for use in humans and/or animals ensure the quality of their operations, including their current risk management approaches and practices for ensuring the quality and suitability of the drug components, containers, and closures that they use. FDA intends to use this information to inform its economic analyses of potential updates to CGMPs for human and animal drug product manufacturing, processing, and packing facilities under 21 CFR parts 210 and 211. Survey respondents will be contacted by email or, if necessary, by regular mail. Respondents will be able to take the survey online or, if requested, they can return a hard copy by mail. FDA estimates the maximum burden of this collection of information as follows:

Table 1—Estimated Burden Hours for One-Time Data Collection ¹

Type of respondent/facility	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Group 1: Facilities in United States engaged in drug manufacturing (in addition to other possible activities)	394	1	394	1.1	433
Group 2: Facilities in United States not engaged in manufacturing but engaged in other forms of drug processing or packing (e.g., labeling, repacking, etc.)	333	1	333	0.75 (45 minutes)	250
Group 3: Facilities outside United States engaged in drug manufacturing (in addition to other possible activities)	407	1	407	2.20	895
Group 4: Facilities outside United States not engaged in manufacturing but engaged in other forms of drug processing or packing (e.g., labeling, repacking, etc.)	261	1	261	1.5	392
Total	1,395		1,395		1,970
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Burden hours are based on pretests of the survey and interviews with industry representatives and reflect the time required by each type of respondent to read the survey invitation and instructions and complete the survey questions. The total estimated one-time burden hours are 1,970.

Dated: September 14, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.