[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         Type of Survey               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
Computer Assisted Telephone           400               1             400               1.13          452
 Interview (CATI)
----------------------------------------------------------------------------------------------------------------
\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