Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, 78974-78975 [2013-30880]
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices
efficiency of the review process.
Although alternative approaches may be
used, if these approaches satisfy the
requirements of the applicable statutes
and regulations. We are requesting the
extension of OMB approval for the
information collection provisions in the
guidance.
Description of Respondents: The
likely respondents include businesses
engaged in the manufacture or sale of
food, food ingredients, and substances
used in materials that come into contact
with food.
In the Federal Register of October 28,
2013 (78 FR 64218), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received. However, the comment was
beyond the scope of the collection of
information’s four topics that are being
solicited. Therefore, it will not be
discussed in this document.
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
§ 25.32(i) ..............................................................................
§ 25.32(o) .............................................................................
§ 25.32(q) .............................................................................
42
1
2
1
1
1
42
1
2
1
1
1
42
1
2
Total ..............................................................................
........................
........................
........................
........................
45
21 CFR Part 25; Environmental impact considerations
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
Total annual
responses
Average burden per response
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The above estimates for respondents
and numbers of responses are based on
the annualized numbers of petitions and
notifications qualifying for § 25.32(i)
and (q) that the Agency has received in
the past 3 years. Please note that in the
past 3 years, there have been no
submissions that requested an action
that would have been subject to the
categorical exclusion in § 25.32(o). To
avoid counting this burden as zero, we
have estimated the burden for this
categorical exclusion at one respondent
making one submission a year for a total
of one annual submission.
To calculate the estimate for the hours
per response values, we assumed that
the information requested for each of
these three categorical exclusions in this
guidance is readily available to the
submitter. For the information requested
for the exclusion in § 25.32(i), we expect
that submitter will need to gather
information from appropriate persons in
the submitter’s company and prepare
this information for attachment to the
claim for categorical exclusion. We
believe that this effort should take no
longer than 1 hour per submission. For
the information requested for the
exclusions in § 25.32(o) and (q), the
submitters will almost always merely
need to copy existing documentation
and attach it to the claim for categorical
exclusion. We believe that collecting
this information should also take no
longer than 1 hour per submission.
Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30998 Filed 12–26–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1558]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 request regarding the
guidance for industry and FDA staff
entitled ‘‘Section 905(j) Reports:
Demonstrating Substantial Equivalence
for Tobacco Products.’’
DATES: Submit either electronic or
written comments on the collection of
information by February 25, 2014.
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
SUMMARY:
PO 00000
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Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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
E:\FR\FM\27DEN1.SGM
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices
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.
Information Request Regarding
Guidance for Industry and FDA Staff
on Section 905(j) Reports:
Demonstrating Substantial Equivalence
for Tobacco Products (OMB Control
Number 0910–0673—Extension)
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a new chapter
granting FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
78975
to reduce tobacco use by minors.
Section 905(j) of the FD&C Act (21
U.S.C. 387e(j)) authorizes FDA to
establish the form for the submission of
information related to substantial
equivalence. In a Level 1 guidance
document issued under the Good
Guidances Practices regulation (21 CFR
10.115), FDA provides
recommendations intended to assist
persons submitting reports under
section 905(j) of the FD&C Act and
explains, among other things, FDA’s
interpretation of the statutory sections
related to substantial equivalence.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C act sections
Number of respondents
Number of responses per
respondent
Total annual
responses
Average
burden per response
Total hours
905(j)(1)(A)(i) and 910(a) .....................................................
1,000
1
1,000
360
360,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on
information it now has available from
interactions with the industry,
information related to other regulated
products, and FDA’s expectations
regarding the tobacco industry’s use of
the section 905(j) pathway to market
their products. Table 1 describes the
annual reporting burden as a result of
the implementation of the substantial
equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21
U.S.C. 387j(a)). FDA estimates that it
will receive 1,000 section 905(j) reports
each year and that it will take a
manufacturer approximately 360 hours
to prepare a report of substantial
equivalence for a new tobacco product.
Therefore, FDA estimates the burden for
submission of substantial equivalence
information will be 360,000 hours.
Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30880 Filed 12–26–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Publication of a Draft of the
Revised Guidebook for the National
Practitioner Data Bank
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
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ACTION:
Notice of Publication of a Draft
of the Revised Guidebook for the
National Practitioner Data Bank.
how to submit comments, visit the
NPDB Web site at: https://
www.npdb.hrsa.gov/news/news.jsp.
The National Practitioner
Data Bank (NPDB) announces the
release of a draft of the revised user
Guidebook. The public is able to request
a copy of the draft of the revised
Guidebook and submit comments to the
NPDB by the deadline below. The
revised Guidebook includes expanded
and improved reporting and querying
examples; useful tables explaining Data
Bank policies; and live links to statutes,
regulations, and the Web site.
The NPDB is a confidential
information clearinghouse created by
Congress intended to facilitate a
comprehensive review of the
professional credentials of health care
practitioners, health care entities,
providers, and suppliers. The
Guidebook is a policy manual that
serves as an essential reference for Data
Bank users to clarify legislative and
regulatory requirements through the use
of reporting and querying examples,
explanations, definitions, and
frequently asked questions (FAQs). The
new Guidebook incorporates legislative
and regulatory changes adopted since its
last edition, including the merger of the
NPDB with the Healthcare Integrity and
Protection Data Bank. Once the
comments have been reviewed, a final
version of the revised Guidebook will be
made available and will replace
previous Guidebooks. For information
on how to request a PDF copy of the
draft Guidebook and instructions on
DATES:
SUMMARY:
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Comments may be submitted
through January 10, 2014. The comment
period may be extended if needed.
Information on any extensions of the
review period will be posted on the Web
site here: https://www.npdb.hrsa.gov/
news/news.jsp.
FOR FURTHER INFORMATION CONTACT:
Ernia P. Hughes, MBA, Acting Director
of the Division of Practitioner Data
Banks at: NPDBPolicy@hrsa.gov or 301–
443–2300.
When
submitting remarks, the NPDB requests
that commenters:
• Reference the page number(s) each
comment addresses; and
• Ensure comments are specific and
relate to the clarity of the NPDB
Guidebook’s content, as regulatory or
statutory concerns are beyond the scope
of this comment process. Comments
should be limited to content-based
feedback that seeks to improve the
examples and FAQs, clarify definitions,
and eliminate ambiguity in the text.
Comments that are not specific to
content clarity and found beyond the
scope of this review will not be
addressed in this process.
SUPPLEMENTARY INFORMATION:
Dated: December 19, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–31119 Filed 12–26–13; 8:45 am]
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]]>Agencies
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78974-78975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1558]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence
for Tobacco Products
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 request
regarding the guidance for industry and FDA staff entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products.''
DATES: Submit either electronic or written comments on the collection
of information by February 25, 2014.
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 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: 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
[[Page 78975]]
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.
Information Request Regarding Guidance for Industry and FDA Staff on
Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products (OMB Control Number 0910-0673--Extension)
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the form for the submission of
information related to substantial equivalence. In a Level 1 guidance
document issued under the Good Guidances Practices regulation (21 CFR
10.115), FDA provides recommendations intended to assist persons
submitting reports under section 905(j) of the FD&C Act and explains,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C act sections Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a)......................................... 1,000 1 1,000 360 360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates
that it will receive 1,000 section 905(j) reports each year and that it
will take a manufacturer approximately 360 hours to prepare a report of
substantial equivalence for a new tobacco product. Therefore, FDA
estimates the burden for submission of substantial equivalence
information will be 360,000 hours.
Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30880 Filed 12-26-13; 8:45 am]
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