
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29716-29717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12398]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1152]


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 June 
22, 2015.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Road, COLE-14526, Silver 
Spring, MD 20993-0002, 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.

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)--
Reinstatement

    The Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 
103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that 
the Secretary of Health and Human Services (the Secretary) 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 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.

[[Page 29717]]

    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) (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. The collection of 
information in Sec.  111.95 has been approved under OMB control number 
0910-0606.
    Description of Respondents: The respondents to this collection of 
information are firms in the dietary supplement industry, including 
dietary supplement manufacturers, packagers and re-packagers, holders, 
labelers and re-labelers, distributors, warehouses, exporters, 
importers, large businesses, and small businesses.
    In the Federal Register of March 9, 2015 (80 FR 12491), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received, but was not 
responsive to the four collection of information topics solicited in 
the notice and, therefore, is not discussed in this document.
    We estimate the annual burden of this collection of information as 
follows:

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

    In the last 3 years, we have not received any new petitions to 
request an exemption from 100 percent identity testing of dietary 
ingredients; therefore, the Agency estimates that one or fewer 
petitions will be submitted annually. Based on our experience with 
petition processes, we estimate it will take a requestor about 8 hours 
to prepare the factual and legal information necessary to support a 
petition for exemption and to prepare the petition. Although we have 
not received any new petitions to request an exemption from 100 percent 
identity testing of dietary ingredients in the last 3 years, we believe 
that OMB approval of these information collection provisions should be 
extended to provide for the potential future need of a firm in the 
dietary supplement industry to petition for an exemption from 100 
percent identity testing of dietary ingredients.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12398 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


