Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Standard on Flavored Cigarettes, 7279-7281 [2010-3036]
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Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
Medical Devices; Exception From
General Requirements for Informed
Consent—21 CFR 50.23 (OMB Control
Number 0910–0586)—Extension
In the Federal Register of June 7, 2006
(71 FR 32827), FDA issued an interim
final rule (hereinafter referred to as the
June 7, 2006, interim final rule) to
amend its regulations to establish a new
exception from the general requirements
for informed consent, to permit the use
of investigational in vitro diagnostic
devices to identify chemical, biological,
radiological, or nuclear agents without
informed consent in certain
circumstances. The agency took this
action because it was concerned that,
during a potential terrorism event or
other potential public health emergency,
delaying the testing of specimens to
obtain informed consent may threaten
the life of the subject. In many
instances, there may also be others who
have been exposed to, or who may be
at risk of exposure to, a dangerous
chemical, biological, radiological, or
nuclear agent, thus necessitating
identification of the agent as soon as
possible. FDA created this exception to
help ensure that individuals who may
have been exposed to a chemical,
biological, radiological, or nuclear agent
are able to benefit from the timely use
of the most appropriate diagnostic
devices, including those that are
investigational.
Section 50.23(e)(1) (21 CFR
50.23(e)(1)) provides an exception to the
general rule that informed consent is
required for the use of an investigational
in vitro diagnostic device. This
exception will apply to those situations
in which the in vitro investigational
diagnostic device is used to prepare for
and respond to a chemical, biological,
radiological, or nuclear terrorism event
or other public health emergency, if the
investigator and an independent
licensed physician make the
determination and later certify in
writing that: (1) There is a lifethreatening situation necessitating the
use of the investigational device; (2)
obtaining informed consent from the
subject is not feasible because there was
no way to predict the need to use the
investigational device when the
specimen was collected and there is not
sufficient time to obtain consent from
the subject or the subject’s legally
authorized representative; and (3) no
satisfactory alternative device is
available. Under the June 7, 2006,
interim final rule these determinations
are made before the device is used, and
the written certifications are made
within 5 working days after the use of
the device. If use of the device is
necessary to preserve the life of the
subject and there is not sufficient time
to obtain the determination of the
independent licensed physician in
advance of using the investigational
device, § 50.23(e)(2) provides that the
certifications must be made within 5
working days of use of the device. In
either case, the certifications are
submitted to the Institutional Review
Board (IRB) within 5 working days of
the use of the device.
Section 50.23(e)(4) provides that an
investigator must disclose the
investigational status of the device and
what is known about the performance
characteristics of the device at the time
test results are reported to the subject’s
health care provider and public health
authorities, as applicable. Under the
June 7, 2006, interim final rule, the
investigator provides the IRB with the
information required by § 50.25 (21 CFR
50.25) (except for the information
described in § 50.25(a)(8)) and the
procedures that will be used to provide
this information to each subject or the
subject’s legally authorized
representative.
FDA estimates the burden of the
collection of information as follows:
TABLE 1.—ESTIMATED AVERAGE ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
of Responses
Total Annual
Responses
Hours per
response
Total hours
50.23(e)(1)(2)
150
3
450
2
900
50.23(e)(4)
150
3
450
1
450
Total
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
1350
are no capital costs or operating and maintenance costs associated with this collection of information
From its knowledge of the industry,
FDA estimates that there are
approximately 150 laboratories that
could perform testing that uses
investigational in vitro diagnostic
devices to identify chemical, biological,
radiological, or nuclear agents. FDA
estimates that in the United States each
year there are approximately 450
naturally occurring cases of diseases or
conditions that are identified in Centers
for Disease Controls’s list of category
‘‘A’’ biological threat agents. The number
of cases that would result from a
terrorist event or other public health
emergency is uncertain. Based on its
knowledge of similar types of
submissions, FDA estimates that it will
take about 2 hours to prepare each
certification.
Based on its knowledge of similar
types of submissions, FDA estimates
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that it will take about 1 hour to prepare
a report disclosing the investigational
status of the in vitro diagnostic device
and what is known about the
performance characteristics of the
device and submit it to the health care
provider and, where appropriate, to
public health authorities.
This interim final rule refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 50.25 have
been approved under 0910–0130.
PO 00000
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3025 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0496]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Product
Standard on Flavored Cigarettes
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 22,
2010.
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 0910–0647. Also
include the FDA 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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Tobacco Product Standard on Flavored
Cigarettes—(OMB Control Number
0910–0647)—Extension
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Public Law 111–31) into
law. The Tobacco Control Act amended
the Federal Food, Drug, and Cosmetic
Act (the 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.
FDA is requesting an extension of an
existing collection of information
pertaining to section 907(a)(1)(A) of the
act (21 U.S.C. 397(a)(1)(A), as amended
by the Tobacco Control Act, which
provides a general tobacco standard
special rule for cigarettes that became
effective on September 22, 2009. This
special rule for cigarettes states in part
that ‘‘* * * a cigarette or any of its
component parts (including the tobacco,
filter, or paper) shall not contain, as a
constituent (including a smoke
constituent) or additive, an artificial or
natural flavor (other than tobacco or
menthol) or an herb or spice, including
strawberry, grape, orange, clove,
cinnamon, pineapple, vanilla, coconut,
licorice, cocoa, chocolate, cherry, or
coffee, that is a characterizing flavor of
the tobacco product or tobacco smoke.’’
As part of our enforcement strategy,
FDA created a Tobacco Call Center
(with a toll-free number) to accept
information from the public about
violations of this provision, known as
the cigarette flavor ban. Callers are able
to report violations of the cigarette
flavor ban and FDA will determine
whether to conduct targeted followup
investigations based on information the
agency receives. Members of the public
who wish to report a violation will be
asked for certain information: Name and
contact information, which are optional,
date that the caller observed or
purchased the alleged violative product,
description of the tobacco product, and
address of the retail outlet or Internet
address where the violative product was
available. FDA developed a form (FDA
Form 3734) that Tobacco Call Center
representatives use to record this
information. Additionally, this form is
posted on FDA’s Internet at https://
www.accessdata.fda.gov/scripts/email/
TobaccoProducts/
flavoredCigarettes.cfm) which allows
the public to report violations of the
cigarette flavor ban by filling out the
form online. Others may simply choose
to send a letter to FDA. (Information
about how to contact FDA’s Center for
Tobacco Products is posted at https://
www.fda.gov/TobaccoProducts/
default.htm).
FDA described how to report
information about possible violations in
a Federal Register notice reminding
regulated industry of the effective date
of the ban on certain flavored cigarettes
(74 FR 48974, September 25, 2009). FDA
also included this information in the
following outreach materials:
• Letter to our tobacco control
partners announcing the cigarette flavor
ban and soliciting information on
possible violations,
• Press release announcing the
effective date of the cigarette flavor ban,
• Flavored tobacco products fact
sheet, and
• Flavored tobacco products parental
advisory.
In the Federal Register of October 26,
2009 (74 FR 55050), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment in response to the 60-day
notice soliciting public comment on the
extension of OMB approval for this
information collection generally
supporting ‘‘the extension of this
collection of information regarding the
enforcement of the cigarette flavor ban
and submits that the extension of data
collection is critical to the ‘proper
performance of FDA’s functions’ and
that it will have great ‘practical utility’.’’
Although FDA did not receive comment
on the estimated number of
respondents, FDA is adjusting this
estimate based on current reporting
experience to 170 respondents.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity and Form FDA 3734
No. of
Respondents
Reporting violations of section
907(a)(1)(A) of the act
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
Annual Frequency
per Response
170
Total Annual
Responses
1
170
Minutes Per
Response
10 (0.167 hours)
are no capital costs or operating and maintenance costs associated with this collection of information.
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PO 00000
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Total Hours
28
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
Dated: February 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[FR Doc. 2010–3036 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
National Center for Injury Prevention
and Control/Initial Review Group,
(NCIPC/IRG)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Translating
Research Into Action for Diabetes
(TRIAD) Legacy Study, Funding
Opportunity Announcement (FOA) DP
10–005, Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Time and Date: 11 a.m.–5 p.m., March 31,
2010 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘TRIAD Legacy Study, FOA DP
10–005.’’
Contact Person for More Information: Don
Blackman, PhD, Scientific Review Officer,
National Center for Chronic Disease and
Health Promotion, Office of the Director,
Extramural Research Program Office, 4770
Buford Highway, NE., Mailstop K–92,
Atlanta, GA 30341, telephone: (770) 488–
3023, e-mail: DBlackman@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–3064 Filed 2–17–10; 8:45 am]
BILLING CODE 4163–18–P
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned review group:
Time and Date: 12:30 p.m.–4 p.m.,
March 3, 2010 (closed).
Place: Teleconference.
Status: The meetings will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5, U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Section 10(d)
of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and
Human Services, and the Director, CDC,
concerning the scientific and technical
merit of grant and cooperative
agreement applications received from
academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct
research that will build the scientific
base for the prevention of unintentional
poisonings from drug overdoses in the
adult population.
Matters to be Discussed: The meeting
will include the review, discussion, and
evaluation of applications intended to
encourage exploratory/developmental
research in unintentional childhood
injury. Requests for Applications are
related to the following individual
research announcement: CE10–002
Unintentional Poisoning from
Prescription Drug Overdoses in Adults
(R21).
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
J. Felix Rogers, PhD, M.P.H., Telephone
(770) 488–4334, NCIPC, CDC, 4770
Buford Highway, NE., Mail Stop F63,
Atlanta, Georgia 30341–3724. The
Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
PO 00000
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7281
Dated: February 4, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–3047 Filed 2–17–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on Monday, March 22, 2010, from
8 a.m. to 6 p.m.
Location: Bethesda Marriott Hotel,
5151 Pooks Hill Rd., Bethesda, MD.,
20814.
Contact Person: Doreen Kezer, Office
of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane (HF–
33), rm. 14–65, Rockville, MD 20857,
301–827–1249, e-mail:
Doreen.Kezer@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
8732310001. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The Pediatric Advisory
Committee will meet to discuss
pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals
for Children Act and the Pediatric
Research Equity Act, for: Anthelios 40,
Cardiolite (technetium Tc-99), Nasacort
AQ (triamcinolone), Viramune
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7279-7281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3036]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0496]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Product
Standard on Flavored Cigarettes
AGENCY: Food and Drug Administration, HHS.
[[Page 7280]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
22, 2010.
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 0910-0647.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tobacco Product Standard on Flavored Cigarettes--(OMB Control Number
0910-0647)--Extension
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the 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.
FDA is requesting an extension of an existing collection of
information pertaining to section 907(a)(1)(A) of the act (21 U.S.C.
397(a)(1)(A), as amended by the Tobacco Control Act, which provides a
general tobacco standard special rule for cigarettes that became
effective on September 22, 2009. This special rule for cigarettes
states in part that ``* * * a cigarette or any of its component parts
(including the tobacco, filter, or paper) shall not contain, as a
constituent (including a smoke constituent) or additive, an artificial
or natural flavor (other than tobacco or menthol) or an herb or spice,
including strawberry, grape, orange, clove, cinnamon, pineapple,
vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that
is a characterizing flavor of the tobacco product or tobacco smoke.''
As part of our enforcement strategy, FDA created a Tobacco Call
Center (with a toll-free number) to accept information from the public
about violations of this provision, known as the cigarette flavor ban.
Callers are able to report violations of the cigarette flavor ban and
FDA will determine whether to conduct targeted followup investigations
based on information the agency receives. Members of the public who
wish to report a violation will be asked for certain information: Name
and contact information, which are optional, date that the caller
observed or purchased the alleged violative product, description of the
tobacco product, and address of the retail outlet or Internet address
where the violative product was available. FDA developed a form (FDA
Form 3734) that Tobacco Call Center representatives use to record this
information. Additionally, this form is posted on FDA's Internet at
https://www.accessdata.fda.gov/scripts/email/TobaccoProducts/flavoredCigarettes.cfm) which allows the public to report violations of
the cigarette flavor ban by filling out the form online. Others may
simply choose to send a letter to FDA. (Information about how to
contact FDA's Center for Tobacco Products is posted at https://www.fda.gov/TobaccoProducts/default.htm).
FDA described how to report information about possible violations
in a Federal Register notice reminding regulated industry of the
effective date of the ban on certain flavored cigarettes (74 FR 48974,
September 25, 2009). FDA also included this information in the
following outreach materials:
Letter to our tobacco control partners announcing the
cigarette flavor ban and soliciting information on possible violations,
Press release announcing the effective date of the
cigarette flavor ban,
Flavored tobacco products fact sheet, and
Flavored tobacco products parental advisory.
In the Federal Register of October 26, 2009 (74 FR 55050), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment in response to the
60-day notice soliciting public comment on the extension of OMB
approval for this information collection generally supporting ``the
extension of this collection of information regarding the enforcement
of the cigarette flavor ban and submits that the extension of data
collection is critical to the `proper performance of FDA's functions'
and that it will have great `practical utility'.'' Although FDA did not
receive comment on the estimated number of respondents, FDA is
adjusting this estimate based on current reporting experience to 170
respondents.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Minutes Per
Activity and Form FDA 3734 Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of section 907(a)(1)(A) of the 170 1 170 10 (0.167 hours) 28
act
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 7281]]
Dated: February 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3036 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
