80 FR 29716 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range		29716-29717
FR Document		2015-12398

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.

Federal Register, Volume 80 Issue 99 (Friday, May 22, 2015)

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29716-29717]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-12398]

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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.

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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 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

29716 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

DEPARTMENT OF HEALTH AND Commonwealth of Puerto Rico, and U.S. information, and incorporating
HUMAN SERVICES territories applying for CSBG funds to accountability measures. The revised
submit an application and plan (Model and automated form may impose an
Administration for Children and State Plan). The Model State Plan must added first-use burden; however, this
Families meet statutory requirements prior to burden will diminish substantially in
being funded with CSBG funds. subsequent years. Copies of the
Submission for OMB Review; Applicants have the option to submit a
Comment Request proposed collection of information/
detailed plan annually or biannually. Model State Plan can be obtained by
Title: Community Services Block Entities that submit a biannual plan visiting http://www.acf.hhs.gov/
Grant (CSBG) Model State Plan. must provide an abbreviated plan the programs/ocs/programs/csbg.
OMB No.: 0970–0382. following year if substantial changes to
Description: Section 676 of the the initial plan will occur. Respondents: State Governments,
Community Services Block Grant This request is to revise the Model including the District of Columbia and
(CSBG) Act requires States, including State Plan format for States by the Commonwealth of Puerto Rico, and
the District of Columbia and the automating the form, streamlining the U.S. territories.

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Model State Plan ............................................................................................. 56 1 33 1,848

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND in brackets in the heading of this
Hours: 1,848. HUMAN SERVICES document.
Additional Information Food and Drug Administration FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
Copies of the proposed collection may and Drug Administration, 8455
[Docket No. FDA–2013–N–1152]
be obtained by writing to the Colesville Road, COLE–14526, Silver
Administration for Children and Agency Information Collection Spring, MD 20993–0002, PRAStaff@
Families, Office of Planning, Research Activities; Submission for Office of fda.hhs.gov.
and Evaluation, 370 L’Enfant Management and Budget Review;
Promenade SW., Washington, DC 20447, Comment Request; Petition To SUPPLEMENTARY INFORMATION: In
Attn: ACF Reports Clearance Officer. All Request an Exemption From 100 compliance with 44 U.S.C. 3507, FDA
requests should be identified by the title Percent Identity Testing of Dietary has submitted the following proposed
of the information collection. Email Ingredients: Current Good collection of information to OMB for
address: infocollection@acf.hhs.gov. Manufacturing Practice in review and clearance.
Manufacturing, Packaging, Labeling, or Petition To Request an Exemption From
OMB Comment Holding Operations for Dietary 100 Percent Identity Testing of Dietary
OMB is required to make a decision Supplements Ingredients: Current Good
concerning the collection of information AGENCY: Food and Drug Administration, Manufacturing Practice in
between 30 and 60 days after HHS. Manufacturing, Packaging, Labeling, or
publication of this document in the ACTION: Notice. Holding Operations for Dietary
Federal Register. Therefore, a comment Supplements—21 CFR 111.75(a)(1)(ii)
is best assured of having its full effect SUMMARY: The Food and Drug (OMB Control Number 0910–0608)—
if OMB receives it within 30 days of Administration (FDA) is announcing Reinstatement
publication. Written comments and that a proposed collection of
information has been submitted to the The Dietary Supplement Health and
recommendations for the proposed
Office of Management and Budget Education Act (DSHEA) (Pub. L. 103–
information collection should be sent
(OMB) for review and clearance under 417) added section 402(g) of the Federal
directly to the following: Office of Food, Drug, and Cosmetic Act (the
Management and Budget, Paperwork the Paperwork Reduction Act of 1995.
FD&C Act) (21 U.S.C. 342(g)), which
Reduction Project, Email: OIRA_ DATES: Fax written comments on the
provides, in part, that the Secretary of
SUBMISSION@OMB.EOP.GOV, Attn: collection of information by June 22, Health and Human Services (the
Desk Officer for the Administration for 2015. Secretary) may, by regulation, prescribe
Children and Families. ADDRESSES: To ensure that comments on good manufacturing practices for dietary
Robert Sargis, the information collection are received, supplements. Section 402(g)(1) of the
OMB recommends that written FD&C Act states that a dietary
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Reports Clearance Officer.
comments be faxed to the Office of supplement is adulterated if ‘‘it has
[FR Doc. 2015–12392 Filed 5–21–15; 8:45 am]
Information and Regulatory Affairs, been prepared, packed, or held under
BILLING CODE 4184–01–P OMB, Attn: FDA Desk Officer, FAX: conditions that do not meet current
202–395–7285, or emailed to oira_ good manufacturing practice
submission@omb.eop.gov. All regulations.’’ Section 701(a) of the FD&C
comments should be identified with the Act (21 U.S.C. 371(a)) gives us the
OMB control number 0910–0608. Also authority to issue regulations for the
include the FDA docket number found efficient enforcement of the FD&C Act.

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Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29717

Part 111 (21 CFR part 111) establishes test or examine 100 percent of the sets forth the information a
the minimum Current Good incoming dietary ingredients for manufacturer is required to submit in
Manufacturing Practice (CGMP) identity can be assured of the identity such a petition. The regulation also
necessary for activities related to of the ingredient. However, we contains a requirement to ensure that
manufacturing, packaging, labeling, or recognize that it may be possible for a the manufacturer keeps our response to
holding dietary supplements to ensure manufacturer to demonstrate, through a petition submitted under
the quality of the dietary supplement. various methods and processes in use § 111.75(a)(1)(ii) as a record under
Section 111.75(a)(1) (21 CFR over time for its particular operation, § 111.95. The collection of information
111.75(a)(1)) establishes a procedure for that a system of less than 100 percent in § 111.95 has been approved under
a petition to request an exemption from identity testing would result in no OMB control number 0910–0606.
100 percent identity testing of dietary material diminution of assurance of the Description of Respondents: The
ingredients. Under § 111.75(a)(1)(ii), identity of the dietary ingredient as respondents to this collection of
manufacturers may request an compared to the assurance provided by information are firms in the dietary
exemption from the requirements set 100 percent identity testing. To provide supplement industry, including dietary
forth in § 111.75(a)(1)(i) when the an opportunity for a manufacturer to supplement manufacturers, packagers
dietary ingredient is obtained from one make such a showing and reduce the and re-packagers, holders, labelers and
or more suppliers identified in the frequency of identity testing of re-labelers, distributors, warehouses,
petition. The regulation clarifies that we components that are dietary ingredients exporters, importers, large businesses,
are willing to consider, on a case-by- from 100 percent to some lower and small businesses.
case basis, a manufacturer’s conclusion, frequency, we added to § 111.75(a)(1) an
supported by appropriate data and exemption from the requirement of 100 In the Federal Register of March 9,
information in the petition submission, percent identity testing when a 2015 (80 FR 12491), FDA published a
that it has developed a system that it manufacturer petitions the Agency for 60-day notice requesting public
would implement as a sound, consistent such an exemption to 100 percent comment on the proposed collection of
means of establishing, with no material identity testing under § 10.30 (21 CFR information. One comment was
diminution of assurance compared to 10.30)and the Agency grants such received, but was not responsive to the
the assurance provided by 100 percent exemption. Such a procedure would be four collection of information topics
identity testing, the identity of the consistent with our stated goal, as solicited in the notice and, therefore, is
dietary ingredient before use. described in the CGMP final rule, of not discussed in this document.
Section 111.75(a)(1) reflects our providing flexibility in the CGMP We estimate the annual burden of this
determination that manufacturers that requirements. Section 111.75(a)(1)(ii) collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number Average
21 CFR section; CGMP requirements for dietary supple- Number of of responses Total annual burden per Total hours
ments respondents per responses response
respondent

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 Dated: May 18, 2015. General Function of the Committee:
received any new petitions to request an Leslie Kux, To provide advice on scientific,
exemption from 100 percent identity Associate Commissioner for Policy. technical, and medical issues
testing of dietary ingredients; therefore, [FR Doc. 2015–12398 Filed 5–21–15; 8:45 am] concerning drug compounding under
the Agency estimates that one or fewer BILLING CODE 4164–01–P sections 503A and 503B of the Federal
petitions will be submitted annually. Food, Drug, and Cosmetic Act (FD&C
Based on our experience with petition Act), and, as required, any other product
processes, we estimate it will take a DEPARTMENT OF HEALTH AND for which FDA has regulatory
requestor about 8 hours to prepare the HUMAN SERVICES responsibility, and make appropriate
factual and legal information necessary recommendations to the Commissioner
Food and Drug Administration
to support a petition for exemption and of Food and Drugs.
to prepare the petition. Although we [Docket No. FDA–2015–N–0001] Date and Time: The meeting will be
have not received any new petitions to held on June 17, 2015, from 8:30 a.m.
request an exemption from 100 percent Pharmacy Compounding Advisory
Committee; Notice of Meeting to 5 p.m., and on June 18, 2015, from
identity testing of dietary ingredients in 8:30 a.m. to 11:30 a.m.
the last 3 years, we believe that OMB AGENCY: Food and Drug Administration,
Location: FDA White Oak Campus,
approval of these information collection HHS.
10903 New Hampshire Ave., Bldg. 31,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

provisions should be extended to ACTION: Notice. Conference Center, the Great Room (Rm.
provide for the potential future need of
This notice announces a forthcoming 1503), Silver Spring, MD 20993–0002.
a firm in the dietary supplement
meeting of a public advisory committee Answers to commonly asked questions
industry to petition for an exemption
of the Food and Drug Administration including information regarding special
from 100 percent identity testing of
(FDA). The meeting will be open to the accommodations due to a disability,
dietary ingredients.
public. visitor parking, and transportation may
Name of Committee: Pharmacy be accessed at: http://www.fda.gov/
Compounding Advisory Committee. AdvisoryCommittees/

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Document Created: 2015-12-15 15:46:22
Document Modified: 2015-12-15 15:46:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by June 22, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road, COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 29716

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration