[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32880-32881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15088]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1011]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Petition To Request 
an Exemption From 100 Percent Identity Testing of Dietary Ingredients: 
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: Fax written comments on the collection of information by August 
15, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0608. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

Petition To Request an Exemption From 100 Percent Identity Testing of 
Dietary Ingredients: Current Good Manufacturing Practice in 
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary 
Supplements--21 CFR 111.75(a)(1)(ii)

OMB Control Number 0910-0608--Extension

    This information collection supports Agency regulations. 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 practices for dietary supplements. 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 the types of conditions that do 
not meet current good manufacturing practice regulations. Section 
701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us the authority to 
issue regulations for the efficient enforcement of the FD&C Act.
    Part 111 (21 CFR part 111) establishes the minimum Current Good 
Manufacturing Practice (CGMP) necessary for activities related to 
manufacturing, packaging, labeling, or holding dietary supplements to 
ensure the quality of the dietary supplement. Section 111.75(a)(1) of 
our regulations (21 CFR 111.75(a)(1)) establishes a procedure for a 
petition to request an exemption from 100 percent identity testing of 
dietary ingredients. Under Sec.  111.75(a)(1)(ii), manufacturers may 
request an exemption from the requirements set forth in Sec.  
111.75(a)(1)(i) when the dietary ingredient is obtained from one or 
more suppliers identified in the petition. The regulation clarifies 
that we are willing to consider, on a case-by-case basis, a 
manufacturer's conclusion, supported by appropriate data and 
information in the petition submission, that it has developed a system 
that it would implement as a sound, consistent means of establishing, 
with no material diminution of assurance compared to the assurance 
provided by 100 percent identity testing, the identity of the dietary 
ingredient before use.
    Section 111.75(a)(1) reflects our 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. To provide 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, we added to Sec.  111.75(a)(1), 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 Sec.  10.30 (21 CFR 10.30) and the Agency grants 
such exemption. Such a procedure would be consistent with our stated 
goal, as described in the CGMP final rule, of providing flexibility in 
the CGMP requirements. Section 111.75(a)(1)(ii) sets forth the 
information a manufacturer is required to submit in such a petition. 
The regulation also contains a requirement to ensure that the 
manufacturer keeps our response to a petition submitted under Sec.  
111.75(a)(1)(ii) as a record under Sec.  111.95 (21 CFR 111.95). The 
collection of information in Sec.  111.95 has been approved under OMB 
control number 0910-0606.
    In the Federal Register of April 9, 2018 (83 FR 15159), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received suggesting that 
``microbial cultures and probiotics should not be required to go 
through such a process to ensure exemption from the Agency's 100 
percent identity testing requirement,'' but did not suggest a revision 
to the estimated burden. We appreciate this comment, however, we 
believe that the current requirements impose minimal information 
collection while simultaneously ensuring the safety of dietary 
supplements.
    We estimate the burden of the information collection as follows:

[[Page 32881]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR section; activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75(a)(1)(ii); Determining whether specifications are met.......               1                1                1                8                8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since OMB's last approval of the information collection, we have 
received no petitions. We therefore retain the currently approved 
estimated burden which assumes no more than one petition will be 
submitted annually. We further assume it would take respondents 8 hours 
to prepare the factual and legal information necessary to support a 
petition for exemption and to prepare the petition, for a total of 8 
burden hours annually. These figures are based on our experience with 
the information collection.

    Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15088 Filed 7-13-18; 8:45 am]
 BILLING CODE 4164-01-P