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Food and Drug Administration, HHS.
Notice.
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 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 the information collection associated with current good manufacturing practice (CGMP) for drugs, finished pharmaceuticals, including medical gases, and active pharmaceutical ingredients (APIs).
Submit either electronic or written comments on the collection of information by May 3, 2021.
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 May 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 3, 2021. 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. ( printed page 12467)
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2011-N-0362 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients.” 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.
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.
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.
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 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 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.
Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients—21 CFR parts 210 and 211 and 21 U.S.C 351(a)(2)(B).
This information collection supports FDA regulations that govern the manufacture, processing, packing, or holding of finished pharmaceuticals, including medical gases, and APIs. Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP regulations. FDA is responsible for enforcing the FD&C Act as well as related statutes, including the Public Health Service Act. Congress enacted these laws to ensure that covered products meet applicable requirements regarding the safety, identity and strength, and the quality and purity characteristics they purport or are represented to possess, and are labeled with adequate warnings and instructions for use.
The pharmaceutical or drug quality-related regulations appear in several parts of Title 21 Code of Federal Regulations (CFR) (Food and Drugs), including sections in parts 1 through 99, 200 through 299, 300 through 499, 600 through 799, and 800 through 1299. The ( printed page 12468) regulations enable a common understanding of the regulatory process by describing requirements to be followed by drug manufacturers, applicants, and FDA. Under part 211 (21 CFR part 211; see 21 CFR 211.94(e)(1)), specific requirements for medical gas containers and closures are also found in the regulations. Finally, the information collection also supports regulations codified under parts 610 and 680 (21 CFR parts 610 and 680), which reference certain CGMP regulations in part 211 (see §§ 610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f)).
These regulations set forth information collection requirements that allow FDA to meet its public health protection responsibilities. Products that fail to comply with CGMP requirements may be rendered adulterated under section 501(a)(2)(B) of the FD&C Act. To demonstrate that their products comply with the requirements of section 501(a)(2)(B), API manufacturers must maintain CGMP records; therefore, we have counted them among respondents who incur burden for the information collection. In the table below, we have included an additional 1,260 respondents to reflect API manufacturers not included in our previous submission for renewal.
To assist respondents with the information collection requirements for medical gases, we developed a draft guidance for industry entitled “Current Good Manufacturing Practice for Medical Gases.” This guidance, when finalized will discuss our recommendations regarding compliance with applicable requirements found in the regulations as they apply to these products. The guidance is available for download from our internet site at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-medical-gases. We believe the recommendations, if followed, will help respondents focus their information collection activities most efficiently with regard to demonstrating regulatory compliance.
We estimate the burden of the information collection as follows:
| Section 501(a)(2)(B) of the FD&C Act; parts 210 and 211 | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| CGMP API Manufacturers | 1,260 | 256 | 322,560 | 0.82 (49.2 minutes) | 264,499 |
| CGMP Finished Pharmaceuticals Manufacturers (excludes medical gases) | 3,270 | 299 | 977,730 | 0.64 (38 minutes) | 625,747 |
| CGMP Medical Gases Manufacturers | 2,284 | 280 | 639,520 | 0.62 (37 minutes) | 396,502 |
| Total | 1,939,810 | 1,286,748 | |||
| 1 There are no capital or operating and maintenance costs associated with the information collection. | |||||
| 2 Records and burden per activity have been averaged and rounded. | |||||
Our estimated burden for the information collection reflects an overall decrease of 29,073 hours and 1,762 records annually for CGMP for finished pharmaceutical manufacturers, excluding those manufacturers of medical gases. Our estimated burden for the information collection also reflects an overall decrease of 486 hours and 1,574 records annually for medical gas manufacturers. Our inclusion of API manufacturers in this collection represents an addition of 264,499 hours and 322,560 records prepared.
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04380 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P
1 comment has been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.