80 FR 12491 - Agency Information Collection Activities; Proposed Collection; 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 45 (March 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12491-12493 | |
| FR Document | 2015-05357 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Notices] [Pages 12491-12493] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05357] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1152] Agency Information Collection Activities; Proposed Collection; 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 an [[Page 12492]] opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our existing regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients. DATES: Submit either electronic or written comments on the collection of information by May 8, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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 Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (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. 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) The Dietary Supplement Health and Education Act (DSHEA) (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 (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. 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. 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. We estimate the burden of this collection of information as follows: [[Page 12493]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR Section; CGMP requirements for Number of responses per Total annual burden per Total hours dietary supplements respondents respondent responses 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: March 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05357 Filed 3-6-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12491
States, and includes input from both concentration of the residue or residues requirements of applicable statutes and
regulatory and industry representatives. present in the edible products (tissues, regulations.
The VICH Steering Committee is milk, eggs, or honey) of animals treated
composed of member representatives IV. Paperwork Reduction Act of 1995
with veterinary drugs. This information
from the European Commission, is used in regulatory submissions This revised guidance refers to
European Medicines Evaluation Agency, around the world. Submission of previously approved collections of
European Federation of Animal Health, regulatory methods (i.e., postapproval information found in FDA regulations.
Committee on Veterinary Medicinal control methods) and the validation These collections of information are
Products, FDA, U.S. Department of requirements of the regulatory methods subject to review by the Office of
Agriculture, the Animal Health are usually well defined by various Management and Budget (OMB) under
Institute, Japanese Veterinary regulatory agencies worldwide and the Paperwork Reduction Act of 1995
Pharmaceutical Association, Japanese might even be defined by national or (44 U.S.C. 3501–3520). The collections
Association of Veterinary Biologics, and regional law. However, the residue of information in 21 CFR part 514 have
Japanese Ministry of Agriculture, depletion studies are generally been approved under OMB control
Forestry, and Fisheries. conducted before the regulatory number 0910–0032.
Six observers are eligible to methods have been completed.
participate in the VICH Steering V. Comments
Oftentimes the in-house validated
Committee: One representative from the residue methods provide the framework Interested persons may submit either
government of Australia/New Zealand, for the methods submitted for regulatory electronic comments regarding this
one representative from the industry in monitoring. Harmonization of the document to www.regulations.gov or
Australia/New Zealand, one validation requirements for written comments to the Division of
representative from the government of methodology used during residue Dockets Management (see ADDRESSES).
Canada, one representative from the depletion studies and submitted to the It is only necessary to send one set of
industry of Canada, one representative regulatory agencies in support of the comments. Identify comments with the
from the government of South Africa, maximum residue limits and docket number found in brackets in the
and one representative from the withdrawal periods should be heading of this document. Received
industry of South Africa. The VICH achievable. It is the intent of this comments may be seen in the Division
Secretariat, which coordinates the document to describe a validation of Dockets Management between 9 a.m.
preparation of documentation, is procedure that is acceptable to the and 4 p.m., Monday through Friday, and
provided by the International regulatory bodies of the VICH regions will be posted to the docket at http://
Federation for Animal Health (IFAH). for use in the residue depletion studies. www.regulations.gov.
An IFAH representative also This validated method could continue
participates in the VICH Steering VI. Electronic Access
on to become the ‘‘regulatory method’’
Committee meetings. but that phase of the process will not be Persons with access to the Internet
addressed in any detail in this guidance. may obtain the guidance at either
II. Revised Guidance on Studies To http://www.fda.gov/AnimalVeterinary/
Evaluate the Metabolism and Residue For purposes of this guidance, the term
‘‘acceptable’’ refers to the scientific GuidanceComplianceEnforcement/
Kinetics of Veterinary Drugs in Food- GuidanceforIndustry/default.htm or
Producing Animals: Validation of evaluation of the analytical method in
terms of the described validation http://www.regulations.gov.
Analytical Methods Used in Residue
Depletion Studies criteria, not to acceptance of the Dated: March 3, 2015.
analytical method as satisfying the Leslie Kux,
In June 2014, the VICH Steering applicable national/regional laws and
Committee agreed that a revised Associate Commissioner for Policy.
regulations of any of the relevant [FR Doc. 2015–05346 Filed 3–6–15; 8:45 am]
guidance document entitled ‘‘Studies to regulatory bodies.
Evaluate the Metabolism and Residue BILLING CODE 4164–01–P
Kinetics of Veterinary Drugs in Food- III. Significance of Guidance
Producing Animals: Validation of As a result of Level 2 revisions, this
Analytical Methods Used in Residue DEPARTMENT OF HEALTH AND
VICH revised guidance is being issued
Depletion Studies’’ (VICH GL49(R)) in final, consistent with FDA’s good HUMAN SERVICES
should be made available to the public. guidance practice (GGP) regulations at Food and Drug Administration
This revised guidance is a revision of a 21 CFR 10.115(g)(4). This guidance,
final guidance on the same topic for developed under the VICH process, has [Docket No. FDA–2013–N–1152]
which a notice of availability was been revised to conform to FDA’s GGP
published in the Federal Register of regulation (21 CFR 10.115). For Agency Information Collection
September 15, 2011 (76 FR 57056). The example, the document has been Activities; Proposed Collection;
revised guidance makes minor changes designated ‘‘guidance’’ rather than Comment Request; Petition To
such as correcting a typographical error ‘‘guideline.’’ In addition, guidance Request an Exemption From 100
in table 2 (Annex 3). Also, the documents must not include mandatory Percent Identity Testing of Dietary
explanatory text for table 2 (Annex 3) language such as ‘‘shall,’’ ‘‘must,’’ Ingredients: Current Good
was revised to correct a description of ‘‘require,’’ or ‘‘requirement,’’ unless Manufacturing Practice in
the statistical model and to provide an FDA is using these words to describe a Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
mstockstill on DSK4VPTVN1PROD with NOTICES
explanation of the procedure used to statutory or regulatory requirement.
generate the data in the table. This This VICH guidance represents the Supplements
revised guidance is a product of the Agency’s current thinking on this topic. AGENCY: Food and Drug Administration,
Metabolism and Residue Kinetics Expert It does not create or confer any rights for HHS.
Working Group of the VICH. or on any person and does not operate ACTION: Notice.
During the veterinary drug to bind FDA or the public. An
development process, residue depletion alternative approach may be used if SUMMARY: The Food and Drug
studies are conducted to determine the such approach satisfies the Administration (FDA) is announcing an
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![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12493
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section; CGMP requirements for dietary supplements responses per burden per Total hours
respondents responses
respondent response
111.75(a)(1)(ii) ..................................................................................... 1 1 1 8 8
1There are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, we have not FOR FURTHER INFORMATION CONTACT: to order by the Council Chair and
received any new petitions to request an Jaime Zimmerman, Designated approval of previous Council summary
exemption from 100 percent identity Management Official, at the Agency for notes. The meeting is open to the public
testing of dietary ingredients; therefore, Healthcare Research and Quality, 540 and will be available via webcast at
the Agency estimates that one or fewer Gaither Road, Rockville, Maryland www.webconferences.com/ahrq . The
petitions will be submitted annually. 20850, (301) 427–1456. For press-related meeting will begin with the AHRQ
Based on our experience with petition information, please contact Alison Hunt Director presenting an update on
processes, we estimate it will take a at (301) 427–1244. current research, programs, and
requestor about 8 hours to prepare the If sign language interpretation or other initiatives. Following the Director’s
factual and legal information necessary reasonable accommodation for a Update, the agenda will include an
to support a petition for exemption and disability is needed, please contact the update on AHRQ insurance-related
to prepare the petition. Although we Food and Drug Administration (FDA) research and a discussion of Patient
have not received any new petitions to Office of Equal Employment Centered Outcomes Research (PCOR)
request an exemption from 100 percent Opportunity and Diversity Management Dissemination and Implementation. The
identity testing of dietary ingredients in on (301) 827–4840, no later than Friday, final agenda will be available on the
the last 3 years, we believe that OMB March 13, 2015. The agenda, roster, and AHRQ Web site at www.AHRQ.gov no
approval of these information collection minutes are available from Ms. Bonnie later than Friday, March 20, 2015.
provisions should be extended to Campbell, Committee Management Dated: March 4, 2015.
provide for the potential future need of Officer, Agency for Healthcare Research
Carla Ladner,
a firm in the dietary supplement and Quality, 540 Gaither Road,
industry to petition for an exemption Rockville, Maryland 20850. Ms. Correspondence Analyst.
from 100 percent identity testing of Campbell’s phone number is (301) 427– [FR Doc. 2015–05399 Filed 3–6–15; 8:45 am]
dietary ingredients. 1554. BILLING CODE 4160–90–P
Dated: March 2, 2015. SUPPLEMENTARY INFORMATION:
Leslie Kux, I. Purpose DEPARTMENT OF HEALTH AND
Associate Commissioner for Policy. The National Advisory Council for HUMAN SERVICES
[FR Doc. 2015–05357 Filed 3–6–15; 8:45 am] Healthcare Research and Quality is
BILLING CODE 4164–01–P authorized by Section 941 of the Public National Institutes of Health
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate, National Institute of Diabetes and
DEPARTMENT OF HEALTH AND the Council is to advise the Secretary of Digestive and Kidney Diseases; Notice
HUMAN SERVICES the Department of Health and Human of Closed Meetings
Agency for Healthcare Research and Services and the Director, Agency for
Pursuant to section 10(d) of the
Quality Healthcare Research and Quality
Federal Advisory Committee Act, as
(AHRQ), on matters related to AHRQ’s
amended (5 U.S.C. App.), notice is
Meeting of the National Advisory conduct of its mission including
hereby given of the following meetings.
Council for Healthcare Research and providing guidance on (A) priorities for
Quality health care research, (B) the field of The meetings will be closed to the
health care research including training public in accordance with the
AGENCY: Agency for Healthcare Research needs and information dissemination on provisions set forth in sections
and Quality (AHRQ), HHS. health care quality and (C) the role of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the Agency in light of private sector as amended. The grant applications and
ACTION: Notice of public meeting.
activity and opportunities for public the discussions could disclose
SUMMARY: In accordance with section private partnerships. confidential trade secrets or commercial
10(a) of the Federal Advisory Committee The Council is composed of members property such as patentable material,
Act, 5 U.S.C. App. 2, this notice of the public, appointed by the and personal information concerning
announces a meeting of the National Secretary, and Federal ex-officio individuals associated with the grant
Advisory Council for Healthcare members specified in the authorizing applications, the disclosure of which
Research and Quality. legislation. would constitute a clearly unwarranted
invasion of personal privacy.
DATES: The meeting will be held on II. Agenda
mstockstill on DSK4VPTVN1PROD with NOTICES
Friday, March 27, 2015, from 8:30 a.m. Name of Committee: National Institute of
On Friday, March 27, 2015, there will Diabetes and Digestive and Kidney Diseases
to 3:00 p.m. be a subcommittee meeting for the Special Emphasis Panel; Hepatitis B Research
ADDRESSES: The meeting will be held at National Healthcare Quality and Network.
the Eisenberg Conference Center, Disparities Report scheduled to begin at Date: March 25, 2015.
Agency for Healthcare Research and 7:30 a.m. The subcommittee meeting is Time: 8:30 a.m. to 5:00 p.m.
Quality, 540 Gaither Road, Rockville, open the public. The Council meeting Agenda: To review and evaluate grant
Maryland 20850. will convene at 8:30 a.m., with the call applications.
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Document Created: 2015-12-18 12:06:06
Document Modified: 2015-12-18 12:06:06
| 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 | Submit either electronic or written comments on the collection of information by May 8, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 12491 |
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