Agency Emergency Processing Under OMB Review; Survey of Manufacturing Practices in the Dietary Supplement Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4235]

Agency Emergency Processing Under OMB Review; Survey of

Manufacturing Practices in the Dietary Supplement Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 emergency processing under the

Paperwork Reduction Act of 1995 (the PRA). The proposed collection of

information is a survey of manufacturing practices of dietary

supplement establishments. The objectives of the survey are to learn

about the existing practices and to help the agency formulate a policy

to ensure that dietary supplements are produced under conditions that

will minimize safety problems resulting from manufacturing without

imposing unnecessary costs to the industry. The survey will provide an

understanding of the economic impact that any proposal to establish

current good manufacturing practice (CGMP) regulations will have on

both large and small firms in the dietary supplement industry.

DATES: Submit written comments on the collection of information by

November 5, 1999.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Desk Officer for FDA. All comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

FDA has requested emergency processing of this proposed collection

of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and

5 CFR 1320.13. The information is essential to the agency's mission of

protecting and promoting public health. The use of normal PRA clearance

procedures would be likely to result in public harm; several recent

illnesses and deaths are suspected to have resulted from the lack of

CGMP for dietary supplements. The hazards associated with poor

manufacturing practices include chemical and biological contaminants,

ingredients not identified on the label, and highly variable amounts of

ingredients. In order to assess the effects of a CGMP regulation, the

agency needs more information about existing manufacturing practices.

FDA invites comments on: (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.

Title: Survey of Manufacturing Practices in the Dietary Supplement

Industry

Under section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 342(g)(2)), FDA may by regulation prescribe CGMP

requirements for dietary supplements in order to ensure that dietary

supplements are not adulterated during the manufacturing process. To

gather information for use in developing CGMP regulations, FDA intends

to conduct a survey of existing manufacturing practices for dietary

supplements. Approximately 717 establishments will be selected from the

universe of 2004 establishments in the Dietary Supplement Enhanced

Establishment Database developed under contract by the Research

Triangle Institute for the agency. The sample allocation is designed to

yield 400 completed surveys. The survey will use a stratified

systematic sample design with stratification by product type and

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establishment size. The product types are vitamins and minerals,

herbals and botanicals, herbal and botanical extracts, amino acids,

proteins, animal extracts, tea-like products, concentrates/metabolites/

constituents, and other dietary supplements. The survey is designed to

determine the extent to which firm's operations use written procedures

and maintain records to ensure that: (1) Personnel have the proper

education, training and experience and are knowledgeable in disease

control and other safety concerns; (2) buildings and facilities are

maintained against contamination; (3) equipment is cleaned and

sanitized; (4) quality control and laboratory operations determine that

certificates of analysis are reliable and that identity and

adulteration tests are conducted on raw materials and in-process

formulations; (5) production and process controls use master and batch

records as well as other records; (6) warehousing and distribution

operations maintain records for forward and backward tracing of

product; and (7) consumer complaints are handled and documented.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden \1\

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Annual

Type of Survey No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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Computer Assisted Telephone 400 1 400 1.13 452

Interview (CATI)

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

These estimates are based on FDA's experience with conducting

industry surveys.

Dated: September 30, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning and Legislation.

[FR Doc. 99-25899 Filed 10-5-99; 8:45 am]

BILLING CODE 4160-01-F