Source: https://www.federalregister.gov/documents/2019/12/05/2019-26250/agency-information-collection-activities-proposed-collection-comment-request-current-good
Timestamp: 2019-12-07 02:45:03
Document Index: 658550684

Matched Legal Cases: ['art 111', 'art 111', 'art 111', 'art 111', 'art 111', '§\u2009111']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Submit either electronic or written comments on the collection of information by February 3, 2020.
84 FR 66678
66678-66680 (3 pages)
2019-26250
FDA-2013-N-1619
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—21 CFR Part 111
OMB Control Number 0910-0606—Revision
https://www.federalregister.gov/d/2019-26250 https://www.federalregister.gov/d/2019-26250
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, 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 the information collection provisions of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements.
Instructions: All submissions received must include the Docket No. FDA-2013-N-1619 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements.” 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.
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 Start Printed Page 66679existing 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.
The Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practice for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after CGMP regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
Accordingly, we have promulgated regulations in part 111 (21 CFR part 111) establishing minimum CGMP requirements pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality. Included among the requirements is recordkeeping, documenting, planning, control, and improvement processes of a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records must show what is being manufactured and whether the controls in place ensure the product's identity, purity, strength, and composition, and that limits on contaminants and measures to prevent adulteration are effective. Further, records must show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. We believe the regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations.
Specifically, the recordkeeping requirements of the regulations in part 111 include establishing written procedures and maintaining records pertaining to: (1) Personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels, and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints.
Section 111.75 (21 CFR 111.75) reflects FDA's determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. Section 111.75 provides an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency. Section 111.75 sets forth the information a manufacturer is required to submit for an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the Agency for such an exemption to 100 percent identity testing under 21 CFR 10.30 and the Agency grants such exemption. This reporting burden is currently accounted for under OMB control number 0910-0608, Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements. With this notice, we propose to consolidate information collection under § 111.75 into the instant and related information collection.
Description of Respondents: Manufacturers, dietary supplement manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry.
111.14; records of personnel practices, including documentation of training 15,000 4 60,000 1 60,000
111.23; records of physical plant sanitation practices, including pest control and water quality 15,000 1 15,000 0.2 (12 minutes) 3,000
111.35; records of equipment and utensils calibration and sanitation practices 400 1 400 12.5 5,000
111.95; records of production and process control systems 250 1 250 45 11,250
111.140; records that quality control personnel must make and keep 240 1,163 279,120 1 279,120
111.180; records associated with components, packaging, labels, and product received for packaging and labeling as a dietary supplement 240 1,163 279,120 1 279,120
111.210; requirements for what the master manufacturing record must include 240 1 240 2.5 600
111.260; requirements for what the batch record must include 145 1,408 204,160 1 204,160
111.325; records that quality control personnel must make and keep for laboratory operations 120 1 120 15 1,800
111.375; records of the written procedures established for manufacturing operations 260 1 260 2 520
111.430; records of the written procedures for packaging and labeling operations 50 1 50 12.6 630
111.475; records of product distribution and procedures for holding and distributing operations 15,000 1 15,000 0.4 (24 minutes) 6,000
111.535; records for returned dietary supplements 110 4 440 13.5 5,940
111.570; records regarding product complaints 240 600 144,000 0.5 (30 minutes) 72,000
Total 929,140
111.75; petition for exemption from 100 percent identity testing 1 1 1 8 8
We have made no changes to our estimate of the information collection based on our most recent review. However, in consolidating burden from information collection previously accounted for under OMB control number 0910-0608, the information collection reflects an increase of 8 hours and one response annually.
[FR Doc. 2019-26250 Filed 12-4-19; 8:45 am]