81 FR 8206 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 32 (February 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8206-8207 | |
| FR Document | 2016-03330 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Pages 8206-8207] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03330] [[Page 8206]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0021] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure 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 March 21, 2016. 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 [email protected]. All comments should be identified with the OMB control number 0910-0495. 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 Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. 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 generally recognized as safe (GRAS) by qualified experts. In the Federal Register of April 17, 1997 (62 FR 18938) (the 1997 proposed rule), 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 that 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 (GRAS) 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. In the Federal Register of September 17, 2015 (80 FR 55857), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received a number of comments in support of the information collection generally. We also received one comment suggesting that the names, credentials, and affiliations of ``qualified experts'' associated with GRAS determinations be included on the form. We received a second comment suggesting that information submitted by manufacturers be reviewed by independent scientists. We appreciate this input. As discussed previously, rulemaking is underway that will necessitate a revision to the information collection provisions associated with our GRAS program and we continue to consider all comments. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Form No.\2\ Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 170.36 (CFSAN)............................ 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. [[Page 8207]] Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR Section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 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. 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: February 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03330 Filed 2-17-16; 8:45 am] BILLING CODE 4164-01-P
![8206 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
DEPARTMENT OF HEALTH AND collection of information to OMB for format, or as electronic files on physical
HUMAN SERVICES review and clearance. media with paper signature page. While
we do not expect Form FDA 3667 to
Food and Drug Administration Substances Generally Recognized as
reduce reporting time for respondents,
Safe: Notification Procedure—21 CFR
[Docket No. FDA–2012–N–0021] use of the form helps to expedite our
170.36 and 570.36 (OMB Control
review of the information being
Number 0910–0342)—Extension
Agency Information Collection submitted. For submissions to our
Activities; Submission for Office of Section 409 of the Federal Food, Drug, Center for Veterinary Medicine (CVM),
Management and Budget Review; and Cosmetic Act (FD&C Act) (21 U.S.C. respondents may continue to send
Comment Request; Substances 348) establishes a premarket approval GRAS notices in letter format to the
Generally Recognized as Safe: requirement for ‘‘food additives’’; Agency, as instructed in our Federal
Notification Procedure section 201(s) of the FD&C Act (21 Register notice of June 4, 2010 (75 FR
U.S.C. 321(s)) provides an exclusion to 31800).
AGENCY: Food and Drug Administration, the definition of ‘‘food additive’’ and
HHS. Presently, we have committed to
thus from the premarket approval issuing a final rule regarding
ACTION: Notice. requirement, for uses of substances that ‘‘Substances Generally Recognized as
SUMMARY: The Food and Drug are generally recognized as safe (GRAS) Safe’’ in 2016, as part of a settlement
Administration (FDA) is announcing by qualified experts. In the Federal agreement with the Center for Food
that a proposed collection of Register of April 17, 1997 (62 FR 18938) Safety, which filed a lawsuit in 2014
information has been submitted to the (the 1997 proposed rule), we published seeking to vacate our 1997 proposed
Office of Management and Budget a proposed rule that would establish a rule.
(OMB) for review and clearance under voluntary procedure whereby
Description of Respondents: The
the Paperwork Reduction Act of 1995. manufacturers would notify us about a
respondents to this collection of
DATES: Fax written comments on the
view of a particular use (or uses) of a
information are manufacturers of
collection of information by March 21, substance that is not subject to the
substances used in food and feed.
2016. statutory premarket approval
requirements based on a determination In the Federal Register of September
ADDRESSES: To ensure that comments on 17, 2015 (80 FR 55857), FDA published
that such use is GRAS. Under an interim
the information collection are received, a 60-day notice requesting public
policy announced in the proposed rule,
OMB recommends that written comment on the proposed collection of
comments be faxed to the Office of we invited manufacturers to submit
notices of their independent information. We received a number of
Information and Regulatory Affairs, comments in support of the information
OMB, Attn: FDA Desk Officer, FAX: determinations for review under the
framework of the proposed rule during collection generally. We also received
202–395–7285, or emailed to oira_ one comment suggesting that the names,
submission@omb.eop.gov. All the period between issuance of the
proposal and any final rule based on the credentials, and affiliations of ‘‘qualified
comments should be identified with the experts’’ associated with GRAS
OMB control number 0910–0495. Also proposal. The proposed regulations
(proposed 21 CFR 170.36 and 21 CFR determinations be included on the form.
include the FDA docket number found We received a second comment
in brackets in the heading of this 570.36) provide a standard format for
the voluntary submission of a notice. suggesting that information submitted
document. by manufacturers be reviewed by
To assist respondents in submissions
FOR FURTHER INFORMATION CONTACT: FDA to our Center for Food Safety and independent scientists. We appreciate
PRA Staff, Office of Operations, Food Applied Nutrition (CFSAN), we this input. As discussed previously,
and Drug Administration, 8455 developed Form FDA 3667 entitled rulemaking is underway that will
Colesville Rd., COLE–14526, Silver ‘‘Generally Recognized as Safe (GRAS) necessitate a revision to the information
Spring, MD 20993–0002, PRAStaff@ Notice.’’ The form, and elements collection provisions associated with
fda.hhs.gov. prepared as attachments to the form, our GRAS program and we continue to
SUPPLEMENTARY INFORMATION: In may be submitted in electronic format consider all comments.
compliance with 44 U.S.C. 3507, FDA via the Electronic Submission Gateway We estimate the burden of this
has submitted the following proposed (ESG), or may be submitted in paper collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR Section Form No.2 responses per annual burden Total hours
respondents respondent responses per response
170.36 (CFSAN) ........................... 3667 3 ........................ 40 1 40 150 6,000
570.36 (CVM) ............................... N/A ............................ 20 1 20 150 3,000
Total ...................................... .................................... ........................ ........................ ........................ ........................ 9,000
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
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2 OnlyCFSAN uses Form FDA 3667.
3 Form FDA 3667 may be submitted electronically via the ESG.
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![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8207
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total
21 CFR Section records per burden per Total hours
recordkeepers annual records
recordkeeper recordkeeping
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.
For purposes of this extension DATES: Any industry organization the Medical Devices Dispute Resolution
request, we are retaining our 2012 interested in participating in the Panel, each panel, according to its
estimates. The PRA analysis for the selection of an appropriate nonvoting specialty area, advises the
GRAS final rule will take into account member to represent industry interests Commissioner of Food and Drugs
any changes to the GRAS notification must send a letter stating that interest to regarding recommended classification
procedure as set forth in the final rule FDA by March 21, 2016, (see sections I or reclassification of devices into one of
and we will revise the collection and II for further details). Concurrently, three regulatory categories; advises on
accordingly. nomination materials for prospective any possible risks to health associated
Dated: February 12, 2016. candidates should be sent to FDA by with the use of devices; advises on
March 21, 2016. formulation of product development
Leslie Kux,
ADDRESSES: All statements of interest protocols; reviews premarket approval
Associate Commissioner for Policy.
from industry organizations interested applications for medical devices;
[FR Doc. 2016–03330 Filed 2–17–16; 8:45 am]
in participating in the selection process reviews guidelines and guidance
BILLING CODE 4164–01–P of nonvoting industry representative documents; recommends exemption of
nomination should be sent to Margaret certain devices from the application of
Ames (see FOR FURTHER INFORMATION
DEPARTMENT OF HEALTH AND portions of the Act; advises on the
CONTACT). All nominations for
HUMAN SERVICES necessity to ban a device; and responds
nonvoting industry representatives may
be submitted electronically by accessing to requests from the agency to review
Food and Drug Administration and make recommendations on specific
the FDA Advisory Committee
Membership Nomination Portal: issues or problems concerning the safety
[Docket No. FDA–2016–N–0001] https://www.accessdata.fda.gov/scripts/ and effectiveness of devices. With the
FACTRSPortal/FACTRS/index.cfm or by exception of the Medical Devices
Request for Nominations on Public Dispute Resolution Panel, each panel,
mail to Advisory Committee Oversight
Advisory Panels of the Medical according to its specialty area, may also
and Management Staff, Food and Drug
Devices Advisory Committee make appropriate recommendations to
Administration, 10903 New Hampshire
AGENCY: Food and Drug Administration, Ave., Bldg. 32, Rm. 5103, Silver Spring, the Commissioner of Food and Drugs on
HHS. MD 20993–0002. Information about issues relating to the design of clinical
ACTION: Notice. becoming a member of an FDA advisory studies regarding the safety and
committee can also be obtained by effectiveness of marketed and
SUMMARY: The Food and Drug visiting FDA’s Web site at http://www. investigational devices. The Committee
Administration (FDA) is requesting that fda.gov/AdvisoryCommittees/ also provides recommendations to the
any industry organizations interested in default.htm. Commissioner or designee on
participating in the selection of FOR FURTHER INFORMATION CONTACT: complexity categorization of in vitro
nonvoting industry representatives to Margaret Ames, Center for Devices and diagnostics under the Clinical
serve on certain panels of the Medical Radiological Health, Food and Drug Laboratory Improvement Amendments
Devices Advisory Committee (MDAC) in Administration, 10903 New Hampshire of 1988.
the Center for Devices and Radiological Ave., Bldg. 66, Rm. 5215, Silver Spring,
Health (CDRH) notify FDA in writing. A. Anesthesiology and Respiratory
MD 20993, 301–796–5960, Fax: 301–
FDA is also requesting nominations for 847–8505, margaret.ames@fda.hhs.gov. Therapy Devices Panel
nonvoting industry representatives to SUPPLEMENTARY INFORMATION: The Reviews and evaluates data
serve on certain device Panels of the Agency is requesting nominations for concerning the safety and effectiveness
MDAC in the CDRH. A nominee may nonvoting industry representatives to of marketed and investigational devices
either be self-nominated or nominated certain panels identified in the for use in anesthesiology and respiratory
by an organization to serve as a following paragraphs: therapy and makes appropriate
nonvoting industry representative.
I. Medical Devices Advisory Committee recommendations to the Commissioner
Nominations will be accepted for
of Food and Drugs.
current and upcoming vacancies The Committee reviews and evaluates
mstockstill on DSK4VPTVN1PROD with NOTICES
effective with this notice. FDA seeks to data on the safety and effectiveness of B. Ear, Nose and Throat Devices Panel
include the views of women, and men, marketed and investigational devices
members of all racial and ethnic groups and makes recommendations for their Reviews and evaluates data
and individuals with and without regulation. The panels engage in a concerning the safety and effectiveness
disabilities on its advisory committees number of activities to fulfill the of marketed and investigational ear,
and, therefore encourages nominations functions the Federal Food, Drug, and nose and throat devices and makes
of appropriately qualified candidates Cosmetic Act envisions for device appropriate recommendations to the
from these groups. advisory panels. With the exception of Commissioner of Food and Drugs.
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Document Created: 2016-02-18 07:46:55
Document Modified: 2016-02-18 07:46:55
| 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 March 21, 2016. | |
| 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 | 81 FR 8206 |
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