80 FR 55857 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 180 (September 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 180 (September 17, 2015)
| Page Range | 55857-55859 | |
| FR Document | 2015-23334 |
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)] [Notices] [Pages 55857-55859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23334] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0021] Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 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 solicits comments on the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe (GRAS). DATES: Submit either electronic or written comments on the collection of information by November 16, 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, [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 [[Page 55858]] requirement, we are publishing this notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite 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 our 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. Substances Generally Recognized as Safe: Notification Procedure--21 CFR 170.36 and 570.36 (OMB Control Number 0910-0342)--Extension Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for ``food additives''; section 201(s) of the FD&C Act (21 U.S.C. 321(s)) provides an exclusion to the definition of ``food additive'' and thus from the premarket approval requirement, for uses of substances that are GRAS by qualified experts. In the Federal Register of April 17, 1997 (62 FR 18938), we published a proposed rule that would establish a voluntary procedure whereby manufacturers would notify us about a view of a particular use (or uses) of a substance is not subject to the statutory premarket approval requirements based on a determination that such use is GRAS. Under an interim policy announced in the proposed rule, we invited manufacturers to submit notices of their independent determinations for review under the framework of the proposed rule during the period between issuance of the proposal and any final rule based on the proposal. The proposed regulations (proposed 21 CFR 170.36 and 21 CFR 570.36) provide a standard format for the voluntary submission of a notice. To assist respondents in submissions to our Center for Food Safety and Applied Nutrition (CFSAN), we developed Form FDA 3667 entitled ``Generally Recognized as Safe Notice.'' The form, and elements prepared as attachments to the form, may be submitted in electronic format via the Electronic Submission Gateway (ESG), or may be submitted in paper format, or as electronic files on physical media with paper signature page. While we do not expect Form FDA 3667 to reduce reporting time for respondents, use of the form helps to expedite our review of the information being submitted. For submissions to our Center for Veterinary Medicine (CVM), respondents may continue to send GRAS notices in letter format to the Agency, as instructed in our Federal Register notice of June 4, 2010 (75 FR 31800). Presently, we have committed to issuing a final rule regarding ``Substances Generally Recognized as Safe'' in 2016, as part of a settlement agreement with the Center for Food Safety, which filed a lawsuit in 2014 seeking to vacate our 1997 proposed rule. Description of Respondents: The respondents to this collection of information are manufacturers of substances used in food and feed. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR part FDA Form No.\2\ Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 170.36 (CFSAN)............................ FDA 3667 \3\................ 40 1 40 150 6,000 570.36 (CVM).............................. N/A......................... 20 1 20 150 3,000 ------------------------------------------------------------------------------------------------------------- Total................................. ............................ .............. .............. .............. .............. 9,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Only CFSAN uses Form FDA 3667. \3\ Form FDA 3667 may be submitted electronically via the ESG. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of records Total annual Average burden 21 CFR part recordkeepers per recordkeeper records per recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 170.36(c)(v) (CFSAN)..................................... 40 1 40 15 600 570.36(c)(v) (CVM)....................................... 20 1 20 15 300 ---------------------------------------------------------------------------------------------- Total................................................ ................. ................. ................. ................. 900 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 55859]] For purposes of this extension request, we are retaining our 2012 estimates. The PRA analysis for the GRAS final rule will take into account any changes to the GRAS notification procedure as set forth in the final rule and we will revise the collection accordingly. Dated: September 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-23334 Filed 9-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55857
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Meeting Requests
Combining and Sending Meeting Request Letters for Man-
ufacturers, Importers, and Researchers .......................... 67 1 67 10 670
Meeting Information Packages
Combining and Submitting Meeting Information Packages
for Manufacturers, Importers, and Researchers .............. 67 1 67 18 1,206
Total .............................................................................. ........................ ........................ ........................ ........................ 1,876
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of that it will take respondents 1,206 hours existing collection of information, and
respondents for meeting requests in of time (67 respondents times 18 hours) to allow 60 days for public comment in
Table 1 of this document is based on the to gather, copy, and submit brief response to the notice. This notice
number of meeting requests to be statements about the product, a solicits comments on the information
received over the next 3 years. description of the details of the collection provisions of the Notification
In the next three years of this anticipated meeting, and data and Procedure for Substances Generally
collection, FDA estimates that 67 pre- information that generally would Recognized as Safe (GRAS).
application meetings will be requested. already have been generated for the DATES: Submit either electronic or
The number is not expected to change, planned research and/or product written comments on the collection of
as the public is more experienced in development. information by November 16, 2015.
submitting applications for substantial The total number of burden hours for
ADDRESSES: Submit electronic
equivalence, requests for non- this collection of information is 1,876
comments on the collection of
substantial equivalence, etc. hours (67 hours to prepare and submit
information to http://
Thus, FDA estimates the number of meeting requests and 1,206 hours to
www.regulations.gov. Submit written
manufacturers, importers, researchers, prepare and submit information
comments on the collection of
and investigators who are expected to packages).
information to the Division of Dockets
submit meeting requests in Table 1 of Dated: September 11, 2015. Management (HFA–305), Food and Drug
this document to be 67 (50 year 1 Leslie Kux, Administration, 5630 Fishers Lane, Rm.
requests + 100 year 2 requests + 50 year
Associate Commissioner for Policy. 1061, Rockville, MD 20852. All
3 requests divided by 3). The hours per
[FR Doc. 2015–23332 Filed 9–16–15; 8:45 am] comments should be identified with the
response, which is the estimated
BILLING CODE 4164–01–P docket number found in brackets in the
number of hours that a respondent
heading of this document.
would spend preparing the information
recommended by this guidance to be FOR FURTHER INFORMATION CONTACT: FDA
submitted with a meeting request is DEPARTMENT OF HEALTH AND PRA Staff, Office of Operations, Food
estimated to be approximately 10 hours HUMAN SERVICES and Drug Administration, 8455
each, and the total burden hours are 670 Colesville Rd., COLE–14526, Silver
Food and Drug Administration Spring, MD 20993–0002, PRAStaff@
hours (10 hours preparation/mailing
times 67 average respondents per year). [Docket No. FDA–2012–N–0021] fda.hhs.gov.
Based on FDA’s experience, the Agency SUPPLEMENTARY INFORMATION: Under the
expects it will take respondents this Agency Information Collection PRA (44 U.S.C. 3501–3520), Federal
amount of time to prepare, gather, copy, Activities; Proposed Collection; Agencies must obtain approval from the
and submit brief statements about the Comment Request; Substances Office of Management and Budget
product and a description of the Generally Recognized as Safe: (OMB) for each collection of
purpose and details of the meeting. Notification Procedure information they conduct or sponsor.
FDA’s estimate of the number of AGENCY: Food and Drug Administration, ‘‘Collection of information’’ is defined
respondents for compiling meeting HHS. in 44 U.S.C. 3502(3) and 5 CFR
information packages in Table 1 of this ACTION: Notice. 1320.3(c) and includes Agency requests
document is based on 67 respondents or requirements that members of the
each preparing copies of their SUMMARY: The Food and Drug public submit reports, keep records, or
information package and submitting Administration (FDA or we) is provide information to a third party.
them to FDA, for a total of 1,206 hours announcing an opportunity for public Section 3506(c)(2)(A) of the PRA (44
annually. The hours per response, comment on the proposed collection of U.S.C. 3506(c)(2)(A)) requires Federal
tkelley on DSK3SPTVN1PROD with NOTICES
which is the estimated number of hours certain information by the Agency. Agencies to provide a 60-day notice in
that a respondent would spend Under the Paperwork Reduction Act of the Federal Register concerning each
preparing the information package as 1995 (the PRA), Federal Agencies are proposed collection of information,
recommended by the guidance, is required to publish notice in the including each proposed extension of an
estimated to be approximately 18 hours Federal Register concerning each existing collection of information,
per information package. Based on proposed collection of information, before submitting the collection to OMB
FDA’s experience, the Agency expects including each proposed extension of an for approval. To comply with this
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![Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55859
For purposes of this extension announced advisory committee meeting requesting to speak is greater than can
request, we are retaining our 2012 cannot always be published quickly be reasonably accommodated during the
estimates. The PRA analysis for the enough to provide timely notice. scheduled open public hearing session,
GRAS final rule will take into account Therefore, you should always check the FDA may conduct a lottery to determine
any changes to the GRAS notification Agency’s Web site at http:// the speakers for the scheduled open
procedure as set forth in the final rule www.fda.gov/AdvisoryCommittees/ public hearing session. The contact
and we will revise the collection default.htm and scroll down to the person will notify interested persons
accordingly. appropriate advisory committee meeting regarding their request to speak by
Dated: September 11, 2015. link, or call the advisory committee October 28, 2015.
information line to learn about possible Persons attending FDA’s advisory
Leslie Kux,
modifications before coming to the committee meetings are advised that the
Associate Commissioner for Policy. meeting. Agency is not responsible for providing
[FR Doc. 2015–23334 Filed 9–16–15; 8:45 am] Agenda: Information will be access to electrical outlets.
BILLING CODE 4164–01–P presented to gauge investigator interest FDA welcomes the attendance of the
in exploring potential pediatric public at its advisory committee
development plans for two products in meetings and will make every effort to
DEPARTMENT OF HEALTH AND various stages of development for adult accommodate persons with disabilities.
HUMAN SERVICES cancer indications. The subcommittee If you require accommodations due to a
will consider and discuss issues disability, please contact Lauren D. Tesh
Food and Drug Administration concerning diseases to be studied, at least 7 days in advance of the
[Docket No. FDA–2015–N–0001] patient populations to be included, and meeting.
possible study designs in the FDA is committed to the orderly
Pediatric Oncology Subcommittee of development of these products for conduct of its advisory committee
the Oncologic Drugs Advisory pediatric use. The discussion will also meetings. Please visit our Web site at
Committee; Notice of Meeting provide information to the Agency http://www.fda.gov/
pertinent to the formulation of written AdvisoryCommittees/
AGENCY: Food and Drug Administration, requests for pediatric studies, if
HHS. AboutAdvisoryCommittees/
appropriate. The products under ucm111462.htm for procedures on
ACTION: Notice. consideration are: (1) ABT–414, public conduct during advisory
application submitted by AbbVie, Inc., committee meetings.
This notice announces a forthcoming and (2) Lenvatinib, application
meeting of a public advisory committee Notice of this meeting is given under
submitted by Eisai, Inc. the Federal Advisory Committee Act (5
of the Food and Drug Administration FDA intends to make background
(FDA). The meeting will be open to the U.S.C. app. 2).
material available to the public no later
public. Dated: September 14, 2015.
than 2 business days before the meeting.
Name of Committee: Pediatric If FDA is unable to post the background Jill Hartzler Warner,
Oncology Subcommittee of the material on its Web site prior to the Associate Commissioner for Special Medical
Oncologic Drugs Advisory Committee. meeting, the background material will Programs.
General Function of the Committee: be made publicly available at the [FR Doc. 2015–23366 Filed 9–16–15; 8:45 am]
To provide advice and location of the advisory committee BILLING CODE 4164–01–P
recommendations to the Agency on meeting, and the background material
FDA’s regulatory issues. will be posted on FDA’s Web site after
Date and Time: The meeting will be the meeting. Background material is DEPARTMENT OF HEALTH AND
held on November 19, 2015, from 8 a.m. available at http://www.fda.gov/ HUMAN SERVICES
to 1 p.m. AdvisoryCommittees/Calendar/
Location: FDA White Oak Campus, default.htm. Scroll down to the Health Resources and Services
10903 New Hampshire Ave., Bldg. 31 appropriate advisory committee meeting Administration
Conference Center, the Great Room (Rm. link.
1503), Silver Spring, MD 20993–0002. Alliance for Innovation on Maternal
Procedure: Interested persons may
Answers to commonly asked questions and Child Health Cooperative
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including information regarding special Agreement
orally or in writing, on issues pending
accommodations due to a disability, before the subcommittee. Written AGENCY: Health Resources and Services
visitor parking, and transportation may submissions may be made to the contact Administration (HRSA), Department of
be accessed at: http://www.fda.gov/ person on or before November 4, 2015. Health and Human Services (HHS).
AdvisoryCommittees/ Oral presentations from the public will ACTION: Notice of Single-Case Deviation
AboutAdvisoryCommittees/ be scheduled between approximately from Competition Requirement for the
ucm408555.htm. 9:05 a.m. to 9:35 a.m., and 11:30 a.m. to Alliance for Innovation on Maternal and
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Document Created: 2015-12-15 09:34:22
Document Modified: 2015-12-15 09:34:22
| 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 | Submit either electronic or written comments on the collection of information by November 16, 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 55857 |
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