Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adoption of the Food and Drug Administration Food Code by Local, State, and Tribal Governments, 36097-36098 [2010-15337]
Download as PDF
36097
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR Section
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual
Records
Total Operating
and
Maintenance
Costs
Hours Per
Record
Total Hours
820.198(a) through
(c)
8,924
1
8,924
5
44,620
820.200(a) and (d)
8,924
1
8,924
3
26,772
820.25
8,924
1
8,924
1
8,924
Total
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
1,300,805
3,105,552
are no capital costs associated with this collection of information.
Explanation of Recordkeeping Burden
Estimate
FDA estimates respondents will have
a total annual recordkeeping burden of
approximately 3,105,552 hours. This
figure also consists of approximately
143,052 hours spent on a startup basis
by 734 new firms.
Burden (labor) hour and cost
estimates were originally developed
under FDA contract by Eastern Research
Group, Inc. (ERG) in 1996 when the
CGMP/QS regulation became final.
Additional factors considered in
deriving estimates included the
following:
• Establishment type: Query has been
made of CDRH’s registration/listing data
bank and the current count was 7,748
domestic firms subject to CGMPs. It was
also calculated that each year, the
number of new domestic firms subject
to CGMPs is 734. The average amount
of firms therefore subject to CGMPs over
the 3 years is therefore 8,924 and this
figure has been used to calculate the
total burden. Because the total number
of registered firms is not static, the
number of respondents will fluctuate
from year to year resulting in slight
changes to the overall burden.
• During the last report it was
estimated that this number was 8,963.
When the last set of numbers was
calculated, FDA was still using a paper
based system to register and list firms.
On October 1, 2007, FDA switched to an
electronic system for registration and
listing. Also at that time the Food and
Drug Administration Amendments Act
of 2007 instituted an establishment
registration fee for some types of
facilities. FDA believes that during the
FY 2008 annual registration cycle,
establishments that had previously
registered but were not required to do
so, removed themselves from inventory
of active establishments. FDA believes
that the current figures reported by the
electronic system more accurately
reflect the inventory of registered
establishments.
VerDate Mar<15>2010
16:47 Jun 23, 2010
Jkt 220001
• Potentially affected establishments:
Except for manufacturers, not every type
of firm is subject to every CGMP/QS
requirement. For example, all are
subject to Quality Policy (§ 820.20(a)),
Document Control (§ 820.40), and other
requirements, whereas only
manufacturers and specification
developers are subject to Subpart C,
Design Controls. The type of firm
subject to each requirement was
identified by the ERG.
• FDA estimated the burden hours
(and costs) for the previous CGMP
regulation in 1992. That estimate was
submitted to OMB on May 4, 1992,
under OMB Paperwork Reduction Act
Control Number 0910–0073. It was
approved by OMB on July 16, 1992, and
expired on June 30, 1995. The
methodology used is different than that
used by ERG in estimating incremental
tasks when the new CGMP/QS became
final rule. Nevertheless, the agency
believes its 1992 estimate adequately
represents labor hours (and costs)
needed to comply with previous CGMP
requirements carried over into the new
CGMP/QS regulation. The 1992 estimate
used 9,289 respondents (rather than
8,924 respondents), which compensates
for differences in methodology.
Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15338 Filed 6–23–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0180]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adoption of the
Food and Drug Administration Food
Code by Local, State, and Tribal
Governments
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 July 26,
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 0910–0448. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
Frm 00040
Fmt 4703
Sfmt 4703
E:\FR\FM\24JNN1.SGM
24JNN1
36098
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
collection of information to OMB for
review and clearance.
Adoption of the FDA Food Code by
Local, State, and Tribal Governments—
42 U.S.C. 243(a) (OMB Control Number
0910–0448)—Extension
FDA has developed its model Food
Code to assist and promote consistent
implementation of national food safety
regulatory policy among the local, State,
and tribal governmental agencies that
have primary responsibility for the
regulation or oversight of retail level
food operations. The FDA Food Code
provides a scientifically sound technical
and legal basis for regulating the retail
segment of the food industry. Authority
for providing such assistance is derived
from section 311(a) of the Public Health
Service Act (42 U.S.C. 243(a)). Under 31
U.S.C. 1535, FDA provides assistance to
other Federal agencies such as the
Indian Health Service (IHS).
Nationwide adoption of the model
FDA Food Code is an important step
toward the agency’s goal for consistent,
scientifically sound, and risk-based food
safety standards and practices. A
current, comprehensive, and accurate
inventory of food code adoptions by
States and U.S. territories, local, and
tribal governments is necessary to
determine the status of up-to-date
protection of the U.S. population and to
identify areas where assistance to these
governments may promote the adoption
of regulations based on the FDA Food
Code.
This collection effort, which began in
2001, has had remarkable success with
97 percent participation from State and
territorial governmental agencies. FDA
contracted with the Association of Food
and Drug Officials (AFDO) to conduct
the initial survey using the OMB
approved survey form. The rulemaking
process that local, State, territorial, and
tribal governmental agencies must
follow to adopt the model FDA Food
Code is often a long and complicated
process that can extend for several
years. For this reason, many agencies
have reported that they are still in the
rulemaking process to adopt or update
their food codes. Thus, FDA believes
that extension of OMB approval of the
survey is needed in order to keep the
current database accurate and up-todate. The contractor will collect the
information electronically and/or
telephonically and will be able to
provide respondents with previous
survey responses already in the
database. Respondents to this
information collection are States and
U.S. territories, local, and tribal
governmental agencies.
In the Federal Register of April 14,
2010 (71 FR 19405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Food Code Survey
Respondents
1 There
75
Total Annual
Responses
4
Hours per
Response
300
Total Hours
1
300
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
experience and the number of updates
received in the past 3 years. FDA
estimates that 75 respondents will
provide four quarterly updates each,
resulting in an estimated 300 total
annual responses. The agency estimates
that each quarterly update will take
about 1 hour. Of the 75 respondents,
those who amend their regulations with
changes unrelated to the risk factors and
interventions, and those who are not
adopting model FDA Food Code
provisions, but are incorporating certain
Conference for Food Protection
recommendations only, will likely need
only annual contact.
Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15337 Filed 6–23–10; 8:45 am]
BILLING CODE 4160–01–S
emcdonald on DSK2BSOYB1PROD with NOTICES
Annual Frequency per
Response
VerDate Mar<15>2010
16:47 Jun 23, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Establishment
Pursuant to Section 10413, Part V of
the Patient Protection and Affordable
Care Act (which established Section
399NN of the Public Health Service Act,
as amended); Public Law 111–48, the
Director, Centers for Disease Control
and Prevention (CDC), announces the
establishment of the Advisory
Committee on Breast Cancer in Young
Women.
This committee is established to assist
in creating a national evidence-based
public education and media campaign
to provide age-appropriate messages and
materials to: (1) Increase awareness of
good breast health habits; (2) identify
risk factors based on familial, racial
ethnic and cultural backgrounds; (3)
encourage young women and healthcare
professionals to increase early detection
of breast cancers; and (4) increase the
availability of health information and
other resources for young women
diagnosed with breast cancer.
The Advisory Committee on Breast
Cancer in Young Women will advise the
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Secretary, HHS, the Assistant Secretary
for Health, and the Director, CDC
regarding the formative research,
development, implementation and
evaluation of evidence-based activities
designed to prevent breast cancer
(particularly among those at heightened
risk) and promote the early detection
and support of young women who
develop the disease. The advice
provided by the Committee will assist in
ensuring scientific quality, timeliness,
utility, and dissemination of credible
appropriate messages and resource
materials.
For more information, contact Ena
Wanliss, M.S., Lead Public Health
Advisor, CDC, National Center for
Chronic Disease Prevention and Health
Promotion, Division of Cancer
Prevention and Control, 4770 Buford
Highway, Mailstop K–57, Chamblee,
Georgia 30316, Telephone: 770–488–
4225.
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.
E:\FR\FM\24JNN1.SGM
24JNN1
Agencies
[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36097-36098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15337]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0180]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adoption of the Food
and Drug Administration Food Code by Local, State, and Tribal
Governments
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 July
26, 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 0910-0448.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 36098]]
collection of information to OMB for review and clearance.
Adoption of the FDA Food Code by Local, State, and Tribal Governments--
42 U.S.C. 243(a) (OMB Control Number 0910-0448)--Extension
FDA has developed its model Food Code to assist and promote
consistent implementation of national food safety regulatory policy
among the local, State, and tribal governmental agencies that have
primary responsibility for the regulation or oversight of retail level
food operations. The FDA Food Code provides a scientifically sound
technical and legal basis for regulating the retail segment of the food
industry. Authority for providing such assistance is derived from
section 311(a) of the Public Health Service Act (42 U.S.C. 243(a)).
Under 31 U.S.C. 1535, FDA provides assistance to other Federal agencies
such as the Indian Health Service (IHS).
Nationwide adoption of the model FDA Food Code is an important step
toward the agency's goal for consistent, scientifically sound, and
risk-based food safety standards and practices. A current,
comprehensive, and accurate inventory of food code adoptions by States
and U.S. territories, local, and tribal governments is necessary to
determine the status of up-to-date protection of the U.S. population
and to identify areas where assistance to these governments may promote
the adoption of regulations based on the FDA Food Code.
This collection effort, which began in 2001, has had remarkable
success with 97 percent participation from State and territorial
governmental agencies. FDA contracted with the Association of Food and
Drug Officials (AFDO) to conduct the initial survey using the OMB
approved survey form. The rulemaking process that local, State,
territorial, and tribal governmental agencies must follow to adopt the
model FDA Food Code is often a long and complicated process that can
extend for several years. For this reason, many agencies have reported
that they are still in the rulemaking process to adopt or update their
food codes. Thus, FDA believes that extension of OMB approval of the
survey is needed in order to keep the current database accurate and up-
to-date. The contractor will collect the information electronically
and/or telephonically and will be able to provide respondents with
previous survey responses already in the database. Respondents to this
information collection are States and U.S. territories, local, and
tribal governmental agencies.
In the Federal Register of April 14, 2010 (71 FR 19405), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Food Code Survey Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respondents 75 4 300 1 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA's experience and the number of
updates received in the past 3 years. FDA estimates that 75 respondents
will provide four quarterly updates each, resulting in an estimated 300
total annual responses. The agency estimates that each quarterly update
will take about 1 hour. Of the 75 respondents, those who amend their
regulations with changes unrelated to the risk factors and
interventions, and those who are not adopting model FDA Food Code
provisions, but are incorporating certain Conference for Food
Protection recommendations only, will likely need only annual contact.
Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15337 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S