83 FR 15159 - 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 83, Issue 68 (April 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15159-15161 | |
| FR Document | 2018-07156 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15159-15161] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07156] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1011] 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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 solicits comments on reporting requirements contained in existing FDA 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 June 8, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 8, 2018. The https://www.regulations.gov [[Page 15160]] electronic filing system will accept comments until midnight Eastern Time at the end of June 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-1011 for ``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.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. 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 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) [[Page 15161]] 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 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section/activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 111.75(a)(1)(ii); Determining 1 1 1 8 8 whether specifications are met ---------------------------------------------------------------------------------------------------------------- \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: April 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07156 Filed 4-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15159
effectiveness but for which there was condom users, including the extent of The special controls guidance
sufficient information to establish protection provided by condoms against document also refers to previously
performance standards to provide such various types of sexually transmitted approved collections of information
assurance. Accordingly, FDA has diseases. found in FDA regulations. The
established the above captioned Special Respondents to this collection of collections of information in 21 CFR
Controls Guidance Document regarding information are manufacturers and part 801 have been approved under
the labeling of natural rubber latex repackagers of male condoms made of OMB control number 0910–0485; the
condoms. natural rubber latex without spermicidal collections of information in 21 CFR
Condoms without spermicidal lubricant. FDA expects approximately part 807, subpart E have been approved
lubricant containing nonoxynol 9 are five new manufacturers or repackagers under OMB control number 0910–0120;
classified in class II. They were to enter the market yearly and to and the collections of information in 21
originally classified before the collectively have a third-party CFR part 820 have been approved under
enactment of provisions of the Safe disclosure burden of 60 hours. The OMB control number 0910–0073.
Medical Devices Act of 1990 (Pub. L. number of respondents cited in table 1 The collection of information under
101–629), which broadened the is based on FDA’s database of premarket 21 CFR 801.437 does not constitute a
definition of class II devices and now submissions and the electronic ‘‘collection of information’’ under the
permits FDA to establish special registration and listing database. The PRA. Rather, it is a ‘‘public disclosure
controls beyond performance standards, average burden per disclosure was of information originally supplied by
including guidance documents, to help derived from a study performed for FDA the Federal Government to the recipient
provide reasonable assurance of the by Eastern Research Group, Inc., an for the purpose of disclosure to the
safety and effectiveness of such devices. economic consulting firm, to estimate public’’ (5 CFR 1320.3(c)(2)).
In December 2000, Congress enacted the impact of the 1999 over-the-counter In the Federal Register of November
Public Law 106–554, which directed (OTC) human drug labeling 9, 2017 (82 FR 52056) FDA published a
FDA to ‘‘reexamine existing condom requirements final rule (64 FR 13254, 60-day notice requesting public
labels’’ and ‘‘determine whether the March 17, 1999). Because the packaging comment on the proposed collection of
labels are medically accurate regarding requirements for condoms are similar to information. No comments were
the overall effectiveness or lack of those of many OTC drugs, we believe received in response to the notice.
effectiveness in preventing sexually the burden to design the labeling for We therefore retain the currently
transmitted diseases. . . .’’ In response, OTC drugs is an appropriate proxy for approved burden estimate for the
FDA recommended labeling intended to the estimated burden to design condom information collection, which is as
provide important information for labeling. follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent
Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300 .................................................................. 5 1 5 12 60
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2018. DEPARTMENT OF HEALTH AND certain information by the Agency.
Leslie Kux, HUMAN SERVICES Under the Paperwork Reduction Act of
Associate Commissioner for Policy. 1995 (PRA), Federal Agencies are
Food and Drug Administration required to publish notice in the
[FR Doc. 2018–07153 Filed 4–6–18; 8:45 am]
[Docket No. FDA–2018–N–1011] Federal Register concerning each
BILLING CODE 4164–01–P
proposed collection of information,
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information, and
Comment Request; Petition To to allow 60 days for public comment in
Request an Exemption From 100 response to the notice. This notice
Percent Identity Testing of Dietary solicits comments on reporting
Ingredients: Current Good requirements contained in existing FDA
Manufacturing Practice in regulations governing petitions to
Manufacturing, Packaging, Labeling, or request an exemption from 100 percent
Holding Operations for Dietary identity testing of dietary ingredients.
Supplements DATES: Submit either electronic or
written comments on the collection of
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration,
HHS. information by June 8, 2018.
ACTION: Notice. ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY: The Food and Drug untimely filed comments will not be
Administration (FDA or Agency) is considered. Electronic comments must
announcing an opportunity for public be submitted on or before June 8, 2018.
comment on the proposed collection of The https://www.regulations.gov
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![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15161
necessary for activities related to the assurance provided by 100 percent frequency, we added to § 111.75(a)(1),
manufacturing, packaging, labeling, or identity testing, the identity of the an exemption from the requirement of
holding dietary supplements to ensure dietary ingredient before use. 100 percent identity testing when a
the quality of the dietary supplement. Section 111.75(a)(1) reflects our manufacturer petitions the Agency for
Section 111.75(a)(1) of our regulations determination that manufacturers that such an exemption to 100 percent
(21 CFR 111.75(a)(1)) establishes a test or examine 100 percent of the identity testing under 21 CFR 10.30 and
procedure for a petition to request an incoming dietary ingredients for the Agency grants such exemption.
exemption from 100 percent identity identity can be assured of the identity Such a procedure would be consistent
testing of dietary ingredients. Under of the ingredient. However, we with our stated goal, as described in the
§ 111.75(a)(1)(ii), manufacturers may recognize that it may be possible for a CGMP final rule, of providing flexibility
request an exemption from the manufacturer to demonstrate, through in the CGMP requirements. Section
requirements set forth in various methods and processes in use 111.75(a)(1)(ii) sets forth the
§ 111.75(a)(1)(i) when the dietary over time for its particular operation, information a manufacturer is required
ingredient is obtained from one or more that a system of less than 100 percent to submit in such a petition. The
suppliers identified in the petition. The identity testing would result in no regulation also contains a requirement
regulation clarifies that we are willing to material diminution of assurance of the to ensure that the manufacturer keeps
consider, on a case-by-case basis, a identity of the dietary ingredient as our response to a petition submitted
manufacturer’s conclusion, supported compared to the assurance provided by under § 111.75(a)(1)(ii) as a record
by appropriate data and information in 100 percent identity testing. To provide under § 111.95 (21 CFR 111.95). The
the petition submission, that it has an opportunity for a manufacturer to collection of information in § 111.95 has
developed a system that it would make such a showing and reduce the been approved under OMB control
implement as a sound, consistent means frequency of identity testing of number 0910–0606.
of establishing, with no material components that are dietary ingredients FDA estimates the burden of this
diminution of assurance compared to from 100 percent to some lower collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR section/activity responses per annual burden per Total hours
respondents respondent responses 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 DEPARTMENT OF HEALTH AND by June 8, 2018 to ensure that the
information collection, we have HUMAN SERVICES Agency considers your comment on this
received no petitions. We therefore draft guidance before it begins work on
retain the currently approved estimated Food and Drug Administration the final version of the guidance.
burden, which assumes no more than [Docket No. FDA–2018–D–1201] ADDRESSES: You may submit comments
one petition will be submitted annually. on any guidance at any time as follows:
We further assume it would take Pregnant Women: Scientific and Electronic Submissions
respondents 8 hours to prepare the Ethical Considerations for Inclusion in
factual and legal information necessary Clinical Trials; Draft Guidance; Submit electronic comments in the
to support a petition for exemption and Availability following way:
to prepare the petition, for a total of 8 • Federal eRulemaking Portal:
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the
burden hours annually. These figures
HHS. instructions for submitting comments.
are based on our experience with the
ACTION: Notice of availability. Comments submitted electronically,
information collection.
including attachments, to https://
Dated: April 3, 2018. SUMMARY: The Food and Drug www.regulations.gov will be posted to
Leslie Kux, Administration (FDA or Agency) is the docket unchanged. Because your
Associate Commissioner for Policy.
announcing the availability of a draft comment will be made public, you are
guidance for industry entitled ‘‘Pregnant solely responsible for ensuring that your
[FR Doc. 2018–07156 Filed 4–6–18; 8:45 am]
Women: Scientific and Ethical comment does not include any
BILLING CODE 4164–01–P
Considerations for Inclusion in Clinical confidential information that you or a
Trials.’’ This draft guidance discusses third party may not wish to be posted,
the ethical and scientific issues when such as medical information, your or
considering the inclusion of pregnant anyone else’s Social Security number, or
women in clinical trials of drugs and confidential business information, such
biological products. This draft guidance as a manufacturing process. Please note
sradovich on DSK3GMQ082PROD with NOTICES
is intended to advance scientific that if you include your name, contact
research in pregnant women, and information, or other information that
discusses issues that should be identifies you in the body of your
considered within the framework of comments, that information will be
human subject protection regulations. posted on https://www.regulations.gov.
DATES: Submit either electronic or • If you want to submit a comment
written comments on the draft guidance with confidential information that you
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Document Created: 2018-04-07 02:38:57
Document Modified: 2018-04-07 02:38:57
| 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 June 8, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 15159 |
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