Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 63217-63218 [2013-24804]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices
Confederated Salish and Kootenai Tribes .............................................................................
White Earth Band of Chippewa Indians .................................................................................
The program expansion supplement
awards will support expanded services
to identify and analyze systems to
improve effectiveness and efficiencies
across early childhood programs, share
action plans to improve outcomes,
continue the implementation of and
expand the development of concrete
community plans, and develop peer
learning relationships.
September 30, 2013–September
29, 2014.
DATES:
FOR FURTHER INFORMATION CONTACT:
Statutory Authority: Awards are supported
by section 511(h)(2)(A) of Title V of the
Social Security Act, as added by Section
2951 of the Patient Protection and Affordable
Care Act, Public Law 111–148, also known as
the Affordable Care Act (ACA).
emcdonald on DSK67QTVN1PROD with NOTICES
VerDate Mar<15>2010
18:13 Oct 22, 2013
Jkt 232001
[Docket No. FDA–2013–N–0730]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
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 November
22, 2013.
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 0910–0298. 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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
SUMMARY:
One of the
stated goals of the Tribal MIECHV
program is to support and strengthen
cooperation and coordination, and
promote linkages among various
programs that serve pregnant women,
expectant fathers, young children, and
families, resulting in the establishment
of coordinated and comprehensive early
childhood systems in grantee
communities.
The activities of the four grantees are
expected to result in models for tribal
early learning systems that can be
replicated in other tribal communities
as well as to expand the reach and
impact of technical assistance activities
for the four participating tribal grantees.
In addition, the supplements will
expand the reach and impact of
technical assistance efforts by
supporting and strengthening existing
coordination and collaboration activities
and expanding the scope of additional
such activities in tribal communities.
BILLING CODE 4184–43–P
Food and Drug Administration
ACTION:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–24863 Filed 10–22–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HHS.
Shannon Rudisill, Director, Office of
Child Care, 901 D Street SW.,
Washington, DC 20447. Telephone:
(202) 401–6984; Email:
shannon.rudisill@acf.hhs.gov.
Shannon L. Rudisill,
Director, Office of Child Care.
Pablo, MT .......................................
White Earth, MN .............................
Threshold of Regulation for Substances
Used in Food-Contact Articles—21 CFR
170.39 (OMB Control Number 0910–
0298)—Extension
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)), the use of
a food additive is deemed unsafe unless
one of the following is applicable: (1) It
conforms to an exemption for
investigational use under section 409(j)
of the FD&C Act; (2) it conforms to the
terms of a regulation prescribing its use;
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
63217
25,000
25,000
or (3) in the case of a food additive
which meets the definition of a foodcontact substance in section 409(h)(6),
there is either a regulation authorizing
its use in accordance with section
409(a)(3)(A) or an effective notification
in accordance with section 409(a)(3)(B).
The regulations in § 170.39 (21 CFR
170.39) established a process that
provides the manufacturer with an
opportunity to demonstrate that the
likelihood or extent of migration to food
of a substance used in a food-contact
article is so trivial that the use need not
be the subject of a food additive listing
regulation or an effective notification.
The Agency has established two
thresholds for the regulation of
substances used in food-contact articles.
The first exempts those substances used
in food-contact articles where the
resulting dietary concentration would
be at or below 0.5 part per billion (ppb).
The second exempts regulated direct
food additives for use in food-contact
articles where the resulting dietary
exposure is 1 percent or less of the
acceptable daily intake for these
substances.
In order to determine whether the
intended use of a substance in a foodcontact article meets the threshold
criteria, certain information specified in
§ 170.39(c) must be submitted to FDA.
This information includes the following
components: (1) The chemical
composition of the substance for which
the request is made; (2) detailed
information on the conditions of use of
the substance; (3) a clear statement of
the basis for the request for exemption
from regulation as a food additive; (4)
data that will enable FDA to estimate
the daily dietary concentration resulting
from the proposed use of the substance;
(5) results of a literature search for
toxicological data on the substance and
its impurities; and (6) information on
the environmental impact that would
result from the proposed use.
FDA uses this information to
determine whether the food-contact
article meets the threshold criteria.
Respondents to this information
collection are individual manufacturers
and suppliers of substances used in
food-contact articles (i.e., food
packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of June 26,
2013 (78 FR 38349), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
E:\FR\FM\23OCN1.SGM
23OCN1
63218
Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 170.39
No. of
respondents
No. of
responses
per respondent
Total annual
responses
Average
burden per
response
Total hours
Threshold of regulation for substances used in food-contact articles .......................................................................
7
1
7
48
336
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA
consulted its records of the number of
regulation exemption requests received
in the past three years. The annual
hours per response reporting estimate of
48 hours is based on information
received from representatives of the
food packaging and processing
industries and Agency records.
FDA estimates that approximately 7
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39, for a
total of 336 hours. The threshold of
regulation process offers one advantage
over the premarket notification process
for food-contact substances established
by section 409(h) (OMB control number
0910–0495) in that the use of a
substance exempted by the Agency is
not limited to only the manufacturer or
supplier who submitted the request for
an exemption. Other manufacturers or
suppliers may use exempted substances
in food-contact articles as long as the
conditions of use (e.g., use levels,
temperature, type of food contacted,
etc.) are those for which the exemption
was issued. As a result, the overall
burden on both the Agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and FDA would not
have to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances which is on
display at FDA’s Division of Dockets
Management and on the Internet at
https://www.fda.gov/Food/Ingredients
PackagingLabeling/PackagingFCS/
default.htm. Having the list of exempted
substances publicly available decreases
the likelihood that a company would
submit a food additive petition or a
notification for the same type of foodcontact application of a substance for
which the Agency has previously
granted an exemption from the food
additive listing regulation requirement.
VerDate Mar<15>2010
18:13 Oct 22, 2013
Jkt 232001
Dated: October 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–24804 Filed 10–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1170]
Draft Guidance for Industry on Chronic
Hepatitis C Virus Infection: Developing
Direct-Acting Antiviral Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Chronic Hepatitis C
Virus Infection: Developing DirectActing Antiviral Drugs for Treatment.’’
The purpose of this guidance is to assist
sponsors in all phases of development
of direct-acting antiviral (DAA) drugs
for the treatment of chronic hepatitis C.
This guidance revises and replaces a
previous draft guidance for industry
entitled ‘‘Chronic Hepatitis C Virus
Infection: Developing Direct-Acting
Antiviral Agents for Treatment’’ issued
on September 14, 2010.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 23,
2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Murray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6360,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Chronic Hepatitis C Virus Infection:
Developing Direct-Acting Antiviral
Drugs for Treatment.’’ The purpose of
this guidance is to assist sponsors in all
phases of development of DAA drugs for
the treatment of chronic hepatitis C.
This guidance revises the draft guidance
for industry entitled ‘‘Chronic Hepatitis
C Virus Infection: Developing DirectActing Antiviral Agents for Treatment’’
issued in September 2010. Significant
changes in this revision include:
• Details on phase 2 and phase 3 trial
design options for the evaluation of
interferon (IFN)-free and IFN-containing
¨
regimens in treatment-naıve and
treatment-experienced populations,
including DAA-experienced
populations.
• Revised primary endpoint to
sustained virologic response at 12 weeks
post-treatment cessation.
• Greater emphasis on DAA drug
development in special populations
including trial design options for human
immunodeficiency virus/hepatitis C
virus co-infected patients, patients with
decompensated cirrhosis, and patients
pre- or post-liver transplant.
• More details on clinical virology
considerations for DAA drugs.
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63217-63218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0730]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Threshold of
Regulation for Substances Used in Food-Contact Articles
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
November 22, 2013.
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 0910-0298.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Threshold of Regulation for Substances Used in Food-Contact Articles--
21 CFR 170.39 (OMB Control Number 0910-0298)--Extension
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(a)), the use of a food additive is deemed
unsafe unless one of the following is applicable: (1) It conforms to an
exemption for investigational use under section 409(j) of the FD&C Act;
(2) it conforms to the terms of a regulation prescribing its use; or
(3) in the case of a food additive which meets the definition of a
food-contact substance in section 409(h)(6), there is either a
regulation authorizing its use in accordance with section 409(a)(3)(A)
or an effective notification in accordance with section 409(a)(3)(B).
The regulations in Sec. 170.39 (21 CFR 170.39) established a
process that provides the manufacturer with an opportunity to
demonstrate that the likelihood or extent of migration to food of a
substance used in a food-contact article is so trivial that the use
need not be the subject of a food additive listing regulation or an
effective notification. The Agency has established two thresholds for
the regulation of substances used in food-contact articles. The first
exempts those substances used in food-contact articles where the
resulting dietary concentration would be at or below 0.5 part per
billion (ppb). The second exempts regulated direct food additives for
use in food-contact articles where the resulting dietary exposure is 1
percent or less of the acceptable daily intake for these substances.
In order to determine whether the intended use of a substance in a
food-contact article meets the threshold criteria, certain information
specified in Sec. 170.39(c) must be submitted to FDA. This information
includes the following components: (1) The chemical composition of the
substance for which the request is made; (2) detailed information on
the conditions of use of the substance; (3) a clear statement of the
basis for the request for exemption from regulation as a food additive;
(4) data that will enable FDA to estimate the daily dietary
concentration resulting from the proposed use of the substance; (5)
results of a literature search for toxicological data on the substance
and its impurities; and (6) information on the environmental impact
that would result from the proposed use.
FDA uses this information to determine whether the food-contact
article meets the threshold criteria. Respondents to this information
collection are individual manufacturers and suppliers of substances
used in food-contact articles (i.e., food packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of June 26, 2013 (78 FR 38349), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
[[Page 63218]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
21 CFR 170.39 No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold of regulation for substances used in food-contact 7 1 7 48 336
articles..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA consulted its records of the
number of regulation exemption requests received in the past three
years. The annual hours per response reporting estimate of 48 hours is
based on information received from representatives of the food
packaging and processing industries and Agency records.
FDA estimates that approximately 7 requests per year will be
submitted under the threshold of regulation exemption process of Sec.
170.39, for a total of 336 hours. The threshold of regulation process
offers one advantage over the premarket notification process for food-
contact substances established by section 409(h) (OMB control number
0910-0495) in that the use of a substance exempted by the Agency is not
limited to only the manufacturer or supplier who submitted the request
for an exemption. Other manufacturers or suppliers may use exempted
substances in food-contact articles as long as the conditions of use
(e.g., use levels, temperature, type of food contacted, etc.) are those
for which the exemption was issued. As a result, the overall burden on
both the Agency and the regulated industry would be significantly less
in that other manufacturers and suppliers would not have to prepare,
and FDA would not have to review, similar submissions for identical
components of food-contact articles used under identical conditions.
Manufacturers and other interested persons can easily access an up-to-
date list of exempted substances which is on display at FDA's Division
of Dockets Management and on the Internet at https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm. Having the list
of exempted substances publicly available decreases the likelihood that
a company would submit a food additive petition or a notification for
the same type of food-contact application of a substance for which the
Agency has previously granted an exemption from the food additive
listing regulation requirement.
Dated: October 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24804 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P
