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, 4116-4117 [2011-1276]
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4116
Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
which workers, in the event of
respiratory protection failure (e.g.,
contaminant breakthrough in a cartridge
respirator or stoppage of air flow in a
supplied-air respirator), could escape
safely when the exposure was below the
IDLH value.
Since the establishment of the original
IDLH values in 1974, NIOSH has
continued to review the available
scientific data to improve the protocol
used to derive the acute exposure
guidelines, in addition to the chemicalspecific IDLH values. This draft CIB
represents the most recent update of the
scientific rationale and process used to
derive IDLH values based on health
effects considerations determined
through a critical assessment of the
toxicology and human health effects
data.
The new process relies on a weightof-evidence approach based on
scientific judgment for establishing
IDLH values that allows for the critical
evaluation of the quality and
consistency of the scientific data, and in
extrapolation from the available data to
the IDLH value. The weight-of-evidence
approach refers to the critical
examination of all the available data
from diverse lines of evidence and the
derivation of a scientific interpretation
based on the collective body of data
including its relevance, quality and
reported results. Guidelines are
presented to aid in the selection of the
critical adverse effect, a point of
departure (POD) or the point on the
dose-response curve from which dose
extrapolation is initiated, and applying
default uncertainty factors (UFs) to
derive the IDLH value. Conceptually,
the derivation process presented in this
CIB is similar to that used in other risk
assessment applications including the
process steps of:
• Hazard characterization,
• Identification of critical adverse
effects,
• Identification of a POD,
• Application of an appropriate UF
based on the study and POD, and
• Determination of the final risk
value.
Supplemental information included
within this draft CIB includes (1) An
overview of the literature search strategy
used to identify relevant data, (2) the
scheme used to prioritize and select
chemicals for which an IDLH value will
be established and (3) an overview of
the analysis applied by NIOSH to
develop a scientifically-based approach
for the selection of the UF during the
derivation of IDLH values. In addition,
Appendix A of the draft CIB presents an
example of the derivation of an IDLH
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value for vinyl acetate (CAS #108–50–4)
based on the new process.
3794.
Jonnalynn.Capezzuto@fda.hhs.gov.
Dated: January 13, 2011.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–1301 Filed 1–21–11; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0044]
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;
Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products.
DATES: Submit either electronic or
written comments on the collection of
information by March 25, 2011.
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr. PI50–
400B, Rockville, MD 20850. 301–796–
SUMMARY:
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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.
Information Request Regarding
Guidance for Industry and FDA Staff;
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 important new 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
authorizes FDA to establish the form for
the submission of information related to
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
substantial equivalence (21 U.S.C.
387e(j)). 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.
Estimation of Burden
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
FD&C Act sections
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
905(j) and 910(a) .................................................................
150
1
150
360
54,000
Total .....................................................................................
........................
........................
........................
........................
54,000
There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on
information related to other regulated
products and FDA’s expectations
regarding the tobacco industry’s use of
the 905(j) pathway to market their
products. Table 1 of this document
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. 387e(j) and 387j(a)). FDA
estimates that it will receive 150 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 54,000 hours.
Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1276 Filed 1–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
mstockstill on DSKH9S0YB1PROD with NOTICES
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.
SUMMARY:
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Fax written comments on the
collection of information by February
23, 2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–new and
title ‘‘Prescription Drug
Advertisements’’. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850. 301–
796–3792.
Elizabeth.Berbakos@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.
DATES:
Prescription Drug Advertisements—
(OMB Control Number 0910)—New
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 352(n)) requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks. For prescription drugs and
biologics, section 502(n) of the FD&C
Act requires advertisements to contain
‘‘* * * a true statement * * *’’ of
certain information including ‘‘* * *
information in brief summary relating to
side effects, contraindications, and
effectiveness * * *’’ as required by
regulations issued by FDA. FDA’s
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prescription drug advertising
regulations at § 202.1 (21 CFR 202.1)
describe requirements and standards for
print and broadcast advertisements.
Section 202.1 applies to advertisements
published in journals, magazines, other
periodicals, and newspapers, and
advertisements broadcast through media
such as radio, television, and telephone
communication systems. Print
advertisements must include a brief
summary of each of the risk concepts
from the product’s approved package
labeling (§ 202.1(e)(1)). Advertisements
that are broadcast through media such
as television, radio, or telephone
communications systems must disclose
the major risks from the product’s
package labeling in either the audio or
audio and visual parts of the
presentation (§ 202.1(e)(1)); this
disclosure is known as the ‘‘major
statement.’’ If a broadcast advertisement
omits the major statement, or if the
major statement minimizes the risks
associated with the use of the drug, the
advertisement could render the drug
misbranded in violation of the FD&C
Act, (21 U.S.C. 352(n) and section 201
of the FD&C Act (21 U.S.C. 321(n)), and
FDA’s implementing regulations at
§ 202.1(e).
Advertisements subject to the
requirements at § 202.1 are subject to
the PRA because these advertisements
disclose information to the public. In
addition, § 202.1(e)(6) and (j) include
provisions that are subject to OMB
approval under the PRA. The
information collection requirements in
§ 202.1 have not previously been
submitted to OMB for approval. With
this notice, we are seeking comment on
the proposed information collection.
Reporting to FDA
Section 202.1(e)(6) includes a
provision that is subject to the PRA.
Section 202.1(e)(6) permits a person
who would be adversely affected by the
enforcement of a provision of
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]]>Agencies
[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4116-4117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1276]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0044]
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; Section 905(j)
Reports: Demonstrating Substantial Equivalence for Tobacco Products.
DATES: Submit either electronic or written comments on the collection
of information by March 25, 2011.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr. PI50-400B,
Rockville, MD 20850. 301-796-3794. Jonnalynn.Capezzuto@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 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;
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
important new 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 authorizes FDA to establish the form
for the submission of information related to
[[Page 4117]]
substantial equivalence (21 U.S.C. 387e(j)). 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.
Estimation of Burden
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
FD&C Act sections Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
905(j) and 910(a)............... 150 1 150 360 54,000
-------------------------------------------------------------------------------
Total........................... .............. .............. .............. .............. 54,000
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on information related to other
regulated products and FDA's expectations regarding the tobacco
industry's use of the 905(j) pathway to market their products. Table 1
of this document 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. 387e(j) and
387j(a)). FDA estimates that it will receive 150 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 54,000 hours.
Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1276 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P
