Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) 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.

DATES:

Submit written comments (including recommendations) on the collection of information by June 2, 2023.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to

https://www.reginfo.gov/public/do/PRAMain.

Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0606. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,

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.

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—21 CFR Part 111

OMB Control Number 0910-0606—Extension

The Dietary Supplement Health and Education Act (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 Current Good Manufacturing Practice (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 issued 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(a)(1) (21 CFR 111.75(a)(1)) 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(a)(1) 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(a)(1) also 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.

Description of Respondents:

Respondents to this collection of information include manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. Respondents are from the private sector (for-profit businesses).

In the

Federal Register

of October 14, 2022 (87 FR 62429), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Recordkeeping Burden

1

21 CFR section; activity

Number of

recordkeepers

Number of

records per

recordkeeper

Total annual

records

Average

burden per

recordkeeping

Total hours

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 regarding equipment and utensils, including 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 production 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

1

There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Reporting Burden

1

21 CFR section; activity

Number of

respondents

Number of

responses per

respondent

Total annual

responses

Average

burden per

response

Total hours

111.75; petition for exemption from 100% identity testing

1

1

1

8

8

1

There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. We base our estimates for the recordkeeping and reporting burdens on our experience with the recordkeeping and petition activities.

Dated: April 28, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-09411 Filed 5-2-23; 8:45 am]

BILLING CODE 4164-01-P