Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 46443 [2012-18976]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Since this collection of information
was last approved by OMB on December
2, 2010, its burden has decreased by
407,421 hours, from 408,775 to 1,354
reporting hours. This adjustment is a
result of FDA experience over the past
2 years in the regulation of tobacco
products and is based on the actual
number of establishment registration
and product ingredient submissions
received during this time period. In
2010, when this collection was first
published for public comment in the
Federal Register, FDA attempted to
determine the actual number of tobacco
manufacturers by using the Security and
Exchange Commission’s Standard
Industrial Classification (SIC) codes,
which are identifying codes that appear
in a company’s EDGAR filings to show
the company’s type of business. When
preparing the collection of information
package for publication in 2010, the
tobacco industry codes indicated that
over 10,000 tobacco manufacturers
existed under the SIC codes for tobacco
products and cigarettes. However, upon
further examination of these codes, it
appears that the number of tobacco
manufacturers was greatly inflated, as
the SIC codes included tobacco retail in
addition to tobacco manufacturers. In
addition, no comments were received
from the 2010 initial 60-day Federal
Register notice regarding either the
number of respondents or the number of
reporting burden hours listed in the
notice, so FDA used the collection’s
SIC-researched manufacturer numbers
for this collection of information. Actual
FDA registration and product listing
report submissions and FDA experience
indicate in the past 2 years, the number
of tobacco manufacturers required to
register and list their products and
ingredient listings is approximately 125,
a substantial decrease from the number
of potential respondents listed in 2010.
By applying the revised number of
manufacturers to the burden chart, the
total burden for registration and listing
now is currently estimated to be 1,354
reporting burden hours, much less than
the 408,775 OMB-approved reporting
burden hours stated in 2010.
Based on the actual number of
registration and product ingredient
listing reports received by FDA over the
past 2 years, the number of expected
annual responses is projected to
decrease from 100,000 registration
responses to 200 annual responses, and
from 11,000 annual product ingredient
listing responses to 200 annual product
ingredient responses. The Agency bases
its estimate on the actual number of
registration and listing and product
ingredient listing reports received, its
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experience with the submission of
registration and listing requirements
applicable to other FDA regulated
products, and ongoing interactions with
industry. FDA estimates that the
submission of registration information
as required by section 905 of the FD&C
Act will remain at 3.75 hours per
establishment. Based on the actual
number of registration information
submitted in the past 2 years and its
experience, the Agency estimates that
approximately 200 registrations will be
submitted from 125 tobacco product
establishments annually, for a total 750
hour burden (125 respondents × 1.6
responses per respondent × 3.75 hours
per response).
FDA estimates that the submission of
ingredient listing information as
required by section 904 of the FD&C Act
will remain at 3.0 hours per tobacco
product. Based on the actual number of
product ingredient listings submitted
over the past 2 years and its experience,
the Agency estimates that
approximately 200 ingredient listings
will be submitted from 125 tobacco
establishments, for a total 600 burden
hours (125 respondents × 1.6 responses
per respondent × 3.0 hours per
response).
FDA estimates that obtaining a Dun
and Bradstreet (DUNS) number will take
0.5 hours, and that 8 respondents (1
percent (1.25) of establishments
required to register under section 905
and 5 percent (6.25) of submitters
required to list ingredients under
section 904) will not already have a
DUNS number. The total burden,
therefore, will be 4 hours (8 respondents
× 1 response per respondent × 0.5 hours
per response).
Total burden hours for this collection,
therefore is 1,354 hours (750 + 600 + 4
hours).
Dated: July 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18975 Filed 8–2–12; 8:45 am]
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46443
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On March
27, 2012, the Agency submitted a
proposed collection of information
entitled ’’ General Administrative
Procedures: Citizen Petitions; Petition
for Reconsideration or Stay of Action;
Advisory Opinions’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0183. The
approval expires on June 30, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18976 Filed 8–2–12; 8:45 am]
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]]>Agencies
[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Page 46443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0627]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March 27, 2012, the Agency submitted a
proposed collection of information entitled '' General Administrative
Procedures: Citizen Petitions; Petition for Reconsideration or Stay of
Action; Advisory Opinions'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0183.
The approval expires on June 30, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18976 Filed 8-2-12; 8:45 am]
BILLING CODE 4160-01-P
