[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Notices]
[Pages 54334-54335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25899]
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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
[[Page 54335]]
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
