Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure, 8206-8207 [2016-03330]
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Substances Generally Recognized as
Safe: Notification Procedure—21 CFR
170.36 and 570.36 (OMB Control
Number 0910–0342)—Extension
[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.
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 oira_
submission@omb.eop.gov. 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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
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
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden
per response
Form No.2
170.36 (CFSAN) ...........................
570.36 (CVM) ...............................
3667 3 ........................
N/A ............................
40
20
1
1
40
20
150
150
6,000
3,000
Total ......................................
mstockstill on DSK4VPTVN1PROD with NOTICES
21 CFR Section
....................................
........................
........................
........................
........................
9,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
CFSAN uses Form FDA 3667.
3 Form FDA 3667 may be submitted electronically via the ESG.
2 Only
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19:03 Feb 17, 2016
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E:\FR\FM\18FEN1.SGM
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Total hours
8207
Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total
annual records
Average
burden per
recordkeeping
Total hours
170.36(c)(v) (CFSAN) ..........................................................
570.36(c)(v) (CVM) ..............................................................
40
20
1
1
40
20
15
15
600
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Request for Nominations on Public
Advisory Panels of the Medical
Devices Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on certain panels of the Medical
Devices Advisory Committee (MDAC) in
the Center for Devices and Radiological
Health (CDRH) notify FDA in writing.
FDA is also requesting nominations for
nonvoting industry representatives to
serve on certain device Panels of the
MDAC in the CDRH. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current and upcoming vacancies
effective with this notice. FDA seeks to
include the views of women, and men,
members of all racial and ethnic groups
and individuals with and without
disabilities on its advisory committees
and, therefore encourages nominations
of appropriately qualified candidates
from these groups.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:03 Feb 17, 2016
Jkt 238001
Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by March 21, 2016, (see sections I
and II for further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
March 21, 2016.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives may
be submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal:
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://www.
fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5215, Silver Spring,
MD 20993, 301–796–5960, Fax: 301–
847–8505, margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency is requesting nominations for
nonvoting industry representatives to
certain panels identified in the
following paragraphs:
DATES:
I. Medical Devices Advisory Committee
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act envisions for device
advisory panels. With the exception of
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
the Medical Devices Dispute Resolution
Panel, each panel, according to its
specialty area, advises the
Commissioner of Food and Drugs
regarding recommended classification
or reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the Act; advises on the
necessity to ban a device; and responds
to requests from the agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner of Food and Drugs on
issues relating to the design of clinical
studies regarding the safety and
effectiveness of marketed and
investigational devices. The Committee
also provides recommendations to the
Commissioner or designee on
complexity categorization of in vitro
diagnostics under the Clinical
Laboratory Improvement Amendments
of 1988.
A. Anesthesiology and Respiratory
Therapy Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational devices
for use in anesthesiology and respiratory
therapy and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
B. Ear, Nose and Throat Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational ear,
nose and throat devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
E:\FR\FM\18FEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8206-8207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, 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.
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
