Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure, 2552-2555 [2012-783]
Download as PDF
<![CDATA[
2552
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agencies, including
whether the information shall have
practical utility; (b) the accuracy of the
agencies’ estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer, Administration for
Children and Families.
[FR Doc. 2012–812 Filed 1–17–12; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Child Care and Development
Fund Annual Aggregate Report—ACF–
800.
OMB No.: 0970–0150.
Description: Section 658K of the Child
Care and Development Block Grant Act
of 1990 (Pub. L. 101–508, 42 U.S.C.
9858) requires that States and
Territories submit annual aggregate data
on the children and families receiving
direct services under the Child Care and
Development Fund. The implementing
regulations for the statutorily required
reporting are at 45 CFR 98.70. Annual
aggregate reports include data elements
represented in the ACF–800 reflecting
the scope, type, and methods of child
care delivery. This provides ACF with
the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research.
Consistent with the statute and
regulations, ACF requests extension of
the ACF–800.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–800 ..........................................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
56
1
40
2,240
Estimated Total Annual Burden
Hours: 2,240
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
VerDate Mar<15>2010
16:07 Jan 17, 2012
Jkt 226001
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Food and Drug Administration
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) and new Form FDA 3667,
which may be submitted electronically
via the Electronic Submission Gateway
(ESG).
[Docket No. FDA–2012–N–0021]
DATES:
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–737 Filed 1–17–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
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 an
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the collection of
information by March 19, 2012.
Submit electronic
comments on the collection of
information to https://
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
ADDRESSES:
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, II, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
3793.
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.
tkelley on DSK3SPTVN1PROD with NOTICES
Substances Generally Recognized as
Safe: Notification Procedure—21 CFR
170.36 and 570.36 (OMB Control
Number 0910–0342)—Revision
I. Background
Section 409 of the Federal Food, Drug,
and Cosmetic Act (the 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) provides an
exemption from the definition of ‘‘food
additive’’ and thus from the premarket
approval requirement, for uses of
VerDate Mar<15>2010
16:07 Jan 17, 2012
Jkt 226001
substances that are GRAS by qualified
experts. In the Federal Register of April
17, 1997 (62 FR 18938) (the 1997
proposed rule), FDA published a
proposed rule that would establish a
voluntary procedure whereby
manufacturers would notify FDA about
a view that 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. The proposed
regulations (proposed 21 CFR 170.36
and 21 CFR 570.36) provide a standard
format for the voluntary submission of
a notice. The notice would include a
detailed summary of the data and
information that support the GRAS
determination, and the notifier would
maintain a record of such data and
information. FDA would make the
information describing the subject of the
GRAS notice, and the Agency’s response
to the notice, available in a publicly
accessible file; the entire GRAS notice
would be publicly available consistent
with the Freedom of Information Act
and other Federal disclosure statutes. In
the Federal Register of December 28,
2010 (75 FR 81536) (the GRAS
reopener), FDA announced the
reopening of the comment period for the
1997 proposed rule. The Agency
requested that comments be submitted
by March 28, 2011.
FDA’s Center for Food Safety and
Applied Nutrition (CFSAN) has recently
developed a form that prompts a notifier
to include certain elements of a GRAS
notice in a standard format. New Form
FDA 3667 is entitled ‘‘Generally
Recognized as Safe (GRAS) Notice.’’ The
form, and elements that would be
prepared as attachments to the form,
may be submitted in electronic format
via the ESG, or may be submitted in
paper format, or as electronic files on
physical media with paper signature
page. CFSAN expects that most if not all
businesses filing GRAS notices in the
next 3 years will choose to take
advantage of the option of electronically
submitting their GRAS notice. Thus, the
burden estimate in table 1, line 1 is
based on the expectation of 100 percent
participation in the electronic
submission process.
FDA’s Center for Veterinary Medicine
(CVM) continues to comply with the
GRAS Pilot Program procedures
announced on June 4, 2010 (75 FR
31800).
II. GRAS Information on Form FDA
3667
The GRAS notice submitted to
CFSAN includes the following
information on Form FDA 3667 and in
attachments to the form:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
2553
A. Introductory Information About the
Submission
• Whether the GRAS notice
submission is a new GRAS notice, or an
amendment or supplement to a
previously transmitted GRAS notice;
• Whether the notifier has
determined that all files provided in an
electronic transmission are free of
computer viruses;
• The date of the notifier’s most
recent meeting with FDA before
transmitting a new GRAS notice; and
• The date of any correspondence,
sent to the notifier by FDA, relevant to
an amendment or supplement the
notifier is transmitting.
B. Information About the Notifier
• The name of and contact
information for the notifier, including
the identity of the contact person and
the company name (if applicable); and
• The name of and contact
information for any agent or attorney
who is authorized to act on behalf of the
notifier.
C. General Administrative Information
• The name of the substance that is
the subject of the GRAS notice
submission;
• The format of the submission (i.e.,
paper, electronic, or electronic with a
paper signature page);
• The mode of transmission of any
electronic submission (i.e., ESG or
transmission on physical media such as
CD–ROM or DVD);
• Whether the notifier is referring us
to information already in our files;
• The statutory basis for the notifier’s
determination of GRAS status;
• Whether the notifier has designated
in its submission any information as
trade secret or as confidential
commercial or financial information;
and
• Whether the notifier has attached a
redacted copy of some or all of the
submission.
D. Intended Use
• The intended conditions of use of
the notified substance.
E. Identity
• Information that identifies the
notified substance. For example, there
may be a chemical name and formula
and a standardized registry number.
F. Checklist of Other Elements Not
Completed Directly on Form FDA 3667
• Any additional information about
identity not previously covered;
• Method of manufacture;
• Specifications for food-grade
material;
E:\FR\FM\18JAN1.SGM
18JAN1
2554
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices
• Dietary exposure;
• Self-limiting levels of use;
• Common use in food before 1958 (if
applicable);
• Comprehensive discussion of the
basis for the determination of GRAS
status; and
• Bibliography.
Form FDA 3667 also requires the
signature of a responsible official (or
question whether use of the substance is
GRAS.
agent or attorney) and a list of
attachments.
The information is used by FDA to
evaluate whether the notice provides a
sufficient basis for a conclusion of
GRAS status and whether information
in the notice or otherwise available to
FDA raises issues of public health
significance that lead the Agency to
III. Description of Respondents
The respondents to this collection of
information are manufacturers of
substances used in food and feed.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
21 CFR section
FDA Form No.2
170.36 (CFSAN) ............................
570.36 (CVM) ................................
FDA 3667 3 ...............
N/A ...........................
40
20
1
1
40
20
150
150
6,000
3,000
Total .......................................
..................................
........................
........................
........................
........................
9,000
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Only CFSAN uses Form FDA 3667. CVM continues to comply with the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR
31800).
3 Form FDA 3667 may be submitted electronically via the ESG.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
170.36(c)(v) (CFSAN) ......................................
570.36(c)(v) (CVM) ..........................................
40
20
1
1
40
20
15
15
600
300
Total ..........................................................
............................
............................
............................
............................
900
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
As noted, CFSAN estimates that all of
the future Form FDA 3667 submissions
will be made electronically via the ESG.
While FDA does not charge for the use
of the ESG, FDA requires respondents to
obtain a public key infrastructure
certificate in order to set up the account.
This can be obtained in-house or
outsourced by purchasing a public key
certificate that is valid for 1 year to 3
years. The certificate typically costs
from $20–$30.
Both CFSAN and CVM receive
submissions that are intended by the
submitter to be GRAS notices. Not all of
the submissions received contain
sufficient information to be filed by the
Agency as GRAS notices. In the
December 28, 2010, GRAS reopener,
FDA requested comment on its GRAS
submission filing decision process and
described its current preliminary review
process of GRAS submissions (75 FR
81536, at 81543). Therefore, the Agency
is basing the following estimates on the
number of GRAS notices that have been
filed by the relevant Center.
In the 1997 proposed rule, FDA
estimated that CFSAN would file
approximately 50 GRAS notices per year
and that CVM would file approximately
10 GRAS notices per year. Approval for
VerDate Mar<15>2010
16:07 Jan 17, 2012
Jkt 226001
the GRAS notification program was
granted by OMB on June 16, 1997,
under OMB control number 0910–0342.
In 2009, FDA’s estimate of the annual
number of GRAS notices that will be
filed by CFSAN and CVM was revised
downward from the original PRA
approval, based on the actual number of
GRAS notices filed by CFSAN from
1998 to 2008. In 2009, FDA sought and
OMB approved an estimate that CFSAN
would file 25 GRAS notices and CVM
would file 5 GRAS notices. On June 4,
2010 CVM announced the beginning of
a GRAS Pilot Program (75 FR 31800).
This notice stated that the revised
estimate in the 2009 PRA approval
reflected FDA’s best judgment at the
time as to the number of notices CVM
will file annually through this pilot
program.
For purposes of this extension
request, CFSAN and CVM are reevaluating their estimates of the annual
number of GRAS notices that will be
received by CFSAN and CVM in the
next 3 years, 2012 through 2015. CFSAN
filed 365 GRAS notices during the 13year period from 1998 through 2010, for
an average of approximately 28 GRAS
notices per year. However, recent years
have seen an increase in the number of
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
GRAS notices filed, with 36 notices
filed in both 2008 and 2009 and 55
notices in 2010. Based on an
approximate average from the last 3
years, FDA is revising its estimate of the
annual number of GRAS notices filed by
CFSAN to be 40 or less. CFSAN expects
that most if not all businesses filing
GRAS notices in the next 3 years will
choose to take advantage of the option
of electronically submitting their GRAS
notice. We expect participation to be
100 percent; thus the estimate in Table
1 is based on the burden of that
experience. FDA also is revising its
estimate of the annual number of GRAS
notices submitted to CVM. As noted, on
June 4, 2010, CVM announced the
beginning of a GRAS Pilot Program.
From June 2010 to October 2011, CVM
filed 13 GRAS notices. Based on this
experience, FDA is revising its estimate
of the annual number of GRAS notices
filed by CVM to be 20 or less.
In the 1997 proposed rule, FDA
estimated that the notification
procedures would require 150 hours per
response for the reporting burdens and
15 hours per response for the
recordkeeping burdens for both
proposed sections (§§ 170.36 and
570.36). FDA is retaining these
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices
estimates for this request. The
availability of the form, and the
opportunity to provide the information
in electronic format, could reduce this
estimate. However, as a conservative
approach for the purpose of this
analysis, FDA is assuming that the
availability of the form and the
opportunity to submit the information
in electronic format will have no effect
on the average time to prepare a GRAS
notification.
Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–783 Filed 1–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0756]
Determination That PREZISTA
(darunavir) Tablets, 300 Milligrams
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that PREZISTA (darunavir) Tablets, 300
milligrams (mg), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
darunavir tablets, 300 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6320, Silver Spring,
MD 20993–0002, (301) 796–3472.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:07 Jan 17, 2012
Jkt 226001
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PREZISTA (darunavir) Tablets, 300
mg, is the subject of NDA 21–976, held
by Tibotec, Inc., and initially approved
on June 23, 2006. PREZISTA is a human
immunodeficiency virus (HIV–1)
protease inhibitor indicated for the
treatment of HIV–1 infection in adult
patients. PREZISTA is also indicated for
the treatment of HIV–1 infection in
pediatric patients 6 years of age and
older. PREZISTA must be
coadministered with ritonavir
(PREZISTA/ritonavir) and with other
antiretroviral agents.
PREZISTA (darunavir) Tablets, 300
mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lupin Pharmaceuticals, Inc. (Lupin),
submitted a citizen petition dated
October 14, 2011 (Docket No. FDA–
2011–P–0756), under 21 CFR 10.30,
requesting that the Agency determine
whether PREZISTA (darunavir) Tablets,
300 mg, was withdrawn from sale for
reasons of safety or effectiveness. After
considering the citizen petition and
reviewing Agency records and based on
the information we have at this time,
FDA has determined under § 314.161
that PREZISTA (darunavir) Tablets, 300
mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner
Lupin has identified no data or other
information suggesting that PREZISTA
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
2555
(darunavir) Tablets, 300 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
PREZISTA (darunavir) Tablets, 300 mg,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this product
was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PREZISTA (darunavir)
Tablets, 300 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to PREZISTA
(darunavir) Tablets, 300 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–847 Filed 1–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0020 (formerly
Docket No. 2007D–0249)]
Guidance for Industry: Preparation of
Investigational Device Exemptions and
Investigational New Drug Applications
for Products Intended To Repair or
Replace Knee Cartilage; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Preparation of
IDEs and INDs for Products Intended to
Repair or Replace Knee Cartilage’’ dated
December 2011. The guidance
document provides sponsors of an
investigational device exemption
application (IDE) or an investigational
new drug application (IND)
recommendations about certain
information that should be included in
SUMMARY:
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Pages 2552-2555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-783]
-----------------------------------------------------------------------
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) 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) and new Form FDA 3667, which may be submitted
electronically via the Electronic Submission Gateway (ESG).
DATES: Submit either electronic or written comments on the collection
of information by March 19, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://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
[[Page 2553]]
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-3793.
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.
Substances Generally Recognized as Safe: Notification Procedure--21 CFR
170.36 and 570.36 (OMB Control Number 0910-0342)--Revision
I. Background
Section 409 of the Federal Food, Drug, and Cosmetic Act (the 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)
provides an exemption from 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) (the 1997 proposed rule), FDA published a proposed
rule that would establish a voluntary procedure whereby manufacturers
would notify FDA about a view that 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. The
proposed regulations (proposed 21 CFR 170.36 and 21 CFR 570.36) provide
a standard format for the voluntary submission of a notice. The notice
would include a detailed summary of the data and information that
support the GRAS determination, and the notifier would maintain a
record of such data and information. FDA would make the information
describing the subject of the GRAS notice, and the Agency's response to
the notice, available in a publicly accessible file; the entire GRAS
notice would be publicly available consistent with the Freedom of
Information Act and other Federal disclosure statutes. In the Federal
Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA
announced the reopening of the comment period for the 1997 proposed
rule. The Agency requested that comments be submitted by March 28,
2011.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) has
recently developed a form that prompts a notifier to include certain
elements of a GRAS notice in a standard format. New Form FDA 3667 is
entitled ``Generally Recognized as Safe (GRAS) Notice.'' The form, and
elements that would be prepared as attachments to the form, may be
submitted in electronic format via the ESG, or may be submitted in
paper format, or as electronic files on physical media with paper
signature page. CFSAN expects that most if not all businesses filing
GRAS notices in the next 3 years will choose to take advantage of the
option of electronically submitting their GRAS notice. Thus, the burden
estimate in table 1, line 1 is based on the expectation of 100 percent
participation in the electronic submission process.
FDA's Center for Veterinary Medicine (CVM) continues to comply with
the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR
31800).
II. GRAS Information on Form FDA 3667
The GRAS notice submitted to CFSAN includes the following
information on Form FDA 3667 and in attachments to the form:
A. Introductory Information About the Submission
Whether the GRAS notice submission is a new GRAS notice,
or an amendment or supplement to a previously transmitted GRAS notice;
Whether the notifier has determined that all files
provided in an electronic transmission are free of computer viruses;
The date of the notifier's most recent meeting with FDA
before transmitting a new GRAS notice; and
The date of any correspondence, sent to the notifier by
FDA, relevant to an amendment or supplement the notifier is
transmitting.
B. Information About the Notifier
The name of and contact information for the notifier,
including the identity of the contact person and the company name (if
applicable); and
The name of and contact information for any agent or
attorney who is authorized to act on behalf of the notifier.
C. General Administrative Information
The name of the substance that is the subject of the GRAS
notice submission;
The format of the submission (i.e., paper, electronic, or
electronic with a paper signature page);
The mode of transmission of any electronic submission
(i.e., ESG or transmission on physical media such as CD-ROM or DVD);
Whether the notifier is referring us to information
already in our files;
The statutory basis for the notifier's determination of
GRAS status;
Whether the notifier has designated in its submission any
information as trade secret or as confidential commercial or financial
information; and
Whether the notifier has attached a redacted copy of some
or all of the submission.
D. Intended Use
The intended conditions of use of the notified substance.
E. Identity
Information that identifies the notified substance. For
example, there may be a chemical name and formula and a standardized
registry number.
F. Checklist of Other Elements Not Completed Directly on Form FDA 3667
Any additional information about identity not previously
covered;
Method of manufacture;
Specifications for food-grade material;
[[Page 2554]]
Dietary exposure;
Self-limiting levels of use;
Common use in food before 1958 (if applicable);
Comprehensive discussion of the basis for the
determination of GRAS status; and
Bibliography.
Form FDA 3667 also requires the signature of a responsible official (or
agent or attorney) and a list of attachments.
The information is used by FDA to evaluate whether the notice
provides a sufficient basis for a conclusion of GRAS status and whether
information in the notice or otherwise available to FDA raises issues
of public health significance that lead the Agency to question whether
use of the substance is GRAS.
III. Description of Respondents
The respondents to this collection of information are manufacturers
of substances used in food and feed.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section 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. CVM continues to comply with the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR 31800).
\3\ Form FDA 3667 may be submitted electronically via the ESG.
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.
As noted, CFSAN estimates that all of the future Form FDA 3667
submissions will be made electronically via the ESG. While FDA does not
charge for the use of the ESG, FDA requires respondents to obtain a
public key infrastructure certificate in order to set up the account.
This can be obtained in-house or outsourced by purchasing a public key
certificate that is valid for 1 year to 3 years. The certificate
typically costs from $20-$30.
Both CFSAN and CVM receive submissions that are intended by the
submitter to be GRAS notices. Not all of the submissions received
contain sufficient information to be filed by the Agency as GRAS
notices. In the December 28, 2010, GRAS reopener, FDA requested comment
on its GRAS submission filing decision process and described its
current preliminary review process of GRAS submissions (75 FR 81536, at
81543). Therefore, the Agency is basing the following estimates on the
number of GRAS notices that have been filed by the relevant Center.
In the 1997 proposed rule, FDA estimated that CFSAN would file
approximately 50 GRAS notices per year and that CVM would file
approximately 10 GRAS notices per year. Approval for the GRAS
notification program was granted by OMB on June 16, 1997, under OMB
control number 0910-0342. In 2009, FDA's estimate of the annual number
of GRAS notices that will be filed by CFSAN and CVM was revised
downward from the original PRA approval, based on the actual number of
GRAS notices filed by CFSAN from 1998 to 2008. In 2009, FDA sought and
OMB approved an estimate that CFSAN would file 25 GRAS notices and CVM
would file 5 GRAS notices. On June 4, 2010 CVM announced the beginning
of a GRAS Pilot Program (75 FR 31800). This notice stated that the
revised estimate in the 2009 PRA approval reflected FDA's best judgment
at the time as to the number of notices CVM will file annually through
this pilot program.
For purposes of this extension request, CFSAN and CVM are re-
evaluating their estimates of the annual number of GRAS notices that
will be received by CFSAN and CVM in the next 3 years, 2012 through
2015. CFSAN filed 365 GRAS notices during the 13-year period from 1998
through 2010, for an average of approximately 28 GRAS notices per year.
However, recent years have seen an increase in the number of GRAS
notices filed, with 36 notices filed in both 2008 and 2009 and 55
notices in 2010. Based on an approximate average from the last 3 years,
FDA is revising its estimate of the annual number of GRAS notices filed
by CFSAN to be 40 or less. CFSAN expects that most if not all
businesses filing GRAS notices in the next 3 years will choose to take
advantage of the option of electronically submitting their GRAS notice.
We expect participation to be 100 percent; thus the estimate in Table 1
is based on the burden of that experience. FDA also is revising its
estimate of the annual number of GRAS notices submitted to CVM. As
noted, on June 4, 2010, CVM announced the beginning of a GRAS Pilot
Program. From June 2010 to October 2011, CVM filed 13 GRAS notices.
Based on this experience, FDA is revising its estimate of the annual
number of GRAS notices filed by CVM to be 20 or less.
In the 1997 proposed rule, FDA estimated that the notification
procedures would require 150 hours per response for the reporting
burdens and 15 hours per response for the recordkeeping burdens for
both proposed sections (Sec. Sec. 170.36 and 570.36). FDA is retaining
these
[[Page 2555]]
estimates for this request. The availability of the form, and the
opportunity to provide the information in electronic format, could
reduce this estimate. However, as a conservative approach for the
purpose of this analysis, FDA is assuming that the availability of the
form and the opportunity to submit the information in electronic format
will have no effect on the average time to prepare a GRAS notification.
Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-783 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P
