Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, 11364-11368 [E7-4446]
Download as PDF
<![CDATA[
11364
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices
For Further Information Contact: Christine
Morrison, Ph.D., Scientific Review
Administrator, Centers for Disease Control
and Prevention, 1600 Clifton Road NE.,
Mailstop D72, Atlanta, GA 30333, Telephone
404.639.3098.
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.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–4533 Filed 3–12–07; 8:45 am]
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): The National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP)
Arthritis Program Programmatic
Review
cprice-sewell on PROD1PC66 with NOTICES
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.
Time and Date: 8 a.m.–5 p.m., April 24,
2007 (Closed).
Place: Renaissance Hotel, 590 W. Peachtree
Street NW., Atlanta, GA 30308, telephone
404–881–6000.
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 review, discussion, and
evaluation of the NCCDPHP Arthritis
Program.
For Further Information Contact: Lee Ann
B. Ramsey, Designated Federal Official,
Division of Adult and Community Health,
CDC, 4770 Buford Hwy. NE., Mailstop K51,
Atlanta, GA 30341, Telephone 770–488–
6036.
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.
Jkt 211001
BILLING CODE 4163–18–P
Draft Final Guidance for Industry:
Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and
Vegetables; Availability; Agency
Information Collection Activities;
Submission for Office of Management
and Budget Review; Comment Request
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[Docket No. 2006D–0079]
AGENCY:
Food and Drug Administration,
HHS.
The National Center for
Environmental Health (NCEH) of the
Centers for Disease Control and
Prevention (CDC) Vessel Sanitation
Program (VSP) announces the following
meeting:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
14:58 Mar 12, 2007
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Annual Meeting
BILLING CODE 4163–18–P
VerDate Aug<31>2005
Dated: March 2, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–4537 Filed 3–12–07; 8:45 am]
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft final guidance
document entitled ‘‘Guidance for
Industry: Guide to Minimize Microbial
Food Safety Hazards of Fresh-Cut Fruits
Name: Vessel Sanitation Program: Current
and Vegetables’’ (the draft final fresh-cut
Program Status and Experience to Date with
Program Operations.
guidance). This document complements
Time and Date: 9 a.m. to 4 p.m., April 17,
FDA’s Current Good Manufacturing
2007.
Practice (CGMP) requirements for foods
Location: Auditorium, Port Everglades
by providing specific guidance on the
Administration Building, 1850 Eller Drive,
processing of fresh-cut produce. The
Ft. Lauderdale, Florida 33316.
draft final fresh-cut guidance and the
Status: Open to the public, limited by the
CGMP regulations are intended to assist
space available. The meeting room
processors in minimizing microbial food
accommodates approximately 100 people.
safety hazards common to the
Meeting Objectives: CDC staff, cruise ship
processing of most fresh-cut fruits and
industry representatives, private sanitation
vegetables sold to consumers and retail
consultants, and other interested parties will
meet to discuss the current status of the
establishments in a ready-to-eat form.
Vessel Sanitation Program and experience to
FDA also is announcing that a proposed
date.
collection of information has been
Topics to be discussed include but are not
submitted to the Office of Management
limited to the following:
and Budget (OMB) for review and
• 2006 Program Review,
clearance under the Paperwork
• Updates to the Vessel Sanitation Program
Reduction Act of 1995 (the PRA).
Operations Manual 2005,
• Updates to the Vessel Sanitation Program DATES: Submit written or electronic
comments on the guidance at any time.
Construction Guidelines 2005, and
• Updates on cruise ship outbreaks and
Fax written comments on the collection
Norovirus.
of information by April 12, 2007.
The official record of this meeting will
ADDRESSES: To ensure that comments on
remain open for a period of 15 days following
the information collection are received,
the meeting (through May 1, 2007) so that
OMB recommends that written
additional materials or comments may be
comments be faxed to the Office of
submitted and made part of the record of the
Information and Regulatory Affairs,
meeting.
OMB, Attn: FDA Desk Officer, FAX:
Advanced registration is encouraged.
202–395–6974. Submit written requests
Please provide the following information:
Name, title, company name, mailing address, for single copies of the draft final
telephone number, facsimile number, and eguidance entitled: ‘‘Guidance for
mail address to Lisa Beaumier at 770–488–
Industry: Guide to Minimize Microbial
7138, FAX 770–488–4127, or
Food Safety Hazards for Fresh-Cut
lbeaumier@cdc.gov.
Fruits and Vegetables’’ to the Center for
If you need additional information, please
Food Safety and Applied Nutrition,
contact Lisa Beaumier (see contact
Office of Plant and Dairy Foods (HFS–
information above).
306), 5100 Paint Branch Pkwy., College
Dated: March 5, 2007.
Park, MD 20740, 301–436–1400 or FAX:
James D. Seligman,
301–436–2651. Include a self-addressed
Chief Information Officer, Centers for Disease adhesive label to assist that office in
Control and Prevention.
processing your request.
[FR Doc. E7–4530 Filed 3–12–07; 8:45 am]
Submit written comments on the draft
final guidance, identified with Docket
BILLING CODE 4163–18–P
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\13MRN1.SGM
13MRN1
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices
cprice-sewell on PROD1PC66 with NOTICES
No. 2006D–0079, to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance. A
copy of the draft final guidance is
available for public examination in the
Division of Dockets Management, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain the
draft final guidance at https://
www.cfsan.fda.gov/~dms/
guidance.html.
FOR FURTHER INFORMATION CONTACT:
With regard to the information
collection: Jonna Capezzuto, Office
of the Chief Information Officer
(HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4659.
With regard to the draft final
guidance document: Amy Green,
Center for Food Safety and Applied
Nutrition (HFS–306), Food and
Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, 301–436–2025 or FAX: 301–
436–2651, e-mail:
amy.green@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Fresh-cut fruits and vegetables are
minimally processed fruits and
vegetables that have been altered in
form by peeling, slicing, chopping,
shredding, coring, or trimming, with or
without washing or other treatment,
prior to being packaged for use by the
consumer or a retail establishment. The
methods by which produce is grown,
harvested, and processed may
contribute to its contamination with
pathogens and, consequently, the role of
the produce in transmitting foodborne
illness. Factors such as the high degree
of handling and mixing of the product,
the release of cellular fluids during
cutting or chopping, the high moisture
content of the product, the absence of a
step lethal to pathogens, and the
potential for temperature abuse in the
processing, storage, transport, and retail
display all enhance the potential for
pathogens to survive and grow in freshcut produce.
With this notice, FDA is announcing
the availability of the draft final freshcut guidance. The draft final fresh-cut
guidance is intended to assist processors
in minimizing microbial food safety
hazards common to the processing of
VerDate Aug<31>2005
14:58 Mar 12, 2007
Jkt 211001
most fresh-cut fruits and vegetables sold
to consumers in a ready-to-eat form. The
draft final guidance was revised based
on public comments. This draft final
guidance represents FDA’s current
thinking on the microbiological hazards
presented by most fresh-cut fruits and
vegetables and the recommended
control measures for such hazards in the
processing of such produce. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. You may use an
alternative approach if such approach
satisfies the requirements of the
applicable statutes and regulations. If
you want to discuss an alternative
approach, contact the FDA staff
responsible for implementing this
guidance (see FOR FURTHER INFORMATION
CONTACT).
II. Paperwork Reduction Act of 1995
This draft final guidance contains
information collection provisions that
are subject to review by the OMB under
the PRA (44 U.S.C 3501–3520). Under
the PRA, Federal agencies must obtain
approval from 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
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
before submitting the collection to OMB
for approval. To comply with this
requirement, in the Federal Register of
March 6, 2006 (71 FR 11209), FDA gave
interested persons 60 days to comment
on the information collection provisions
in the draft guidance. FDA received a
number of comments on the draft
guidance but received no comments
regarding the information collection
provisions.
After publishing the 60-day notice
requesting public comment, section
3507 of the PRA (44 U.S.C. 3507)
requires Federal agencies to submit the
proposed collection to OMB for review
and clearance. In compliance with 44
U.S.C. 3507, FDA has submitted the
following proposed collection of
information to OMB for review and
clearance. FDA will not finalize this
guidance unless and until OMB
approves the collection of information.
If the collection is approved, FDA will
publish a notice in the Federal Register
announcing that the guidance is final
and providing an OMB control number.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
11365
Draft Final Guidance for Industry:
Guide to Minimize Food Safety Hazards
for Fresh-Cut Fruits and Vegetables
Description: The Federal Food, Drug,
and Cosmetic Act (the act) prohibits the
distribution of adulterated food in
interstate commerce (21 U.S.C. 331 and
342). In response to the increased
consumption of fresh-cut fruits and
vegetables and the potential for
foodborne illness associated with these
products, FDA recognizes the need for
guidance specific to the processing of
fresh-cut fruits and vegetables.
Accordingly, FDA encourages fresh-cut
produce processors to adopt the general
recommendations in the guidance and
to tailor practices to their individual
operations.
FDA’s draft final fresh-cut guidance
represents the agency’s
recommendations to industry based on
the current state of science. Following
the recommendations set forth in the
fresh-cut guidance is the choice of each
individual fresh-cut operation, plant, or
processor. FDA estimates the burden of
this guidance on industry by assuming
that those in the fresh-cut industry who
do not currently follow the
recommendations put forth in the
guidance will find it of value to do so.
Therefore, the estimates of the burden
associated with the issuance of this
guidance represent the upper bound
estimate of burden, the burden if every
fresh-cut plant, processor, or operation
that does not follow the
recommendations of the guidance
should choose to do so.
A. Industry Profile
Estimates of the paperwork burden to
the fresh-cut industry that may result
from the publication of FDA’s draft final
fresh-cut guidance are based on
information from FDA’s relationship
with a fresh-cut processor who has
developed and maintained these
programs and information from a freshcut produce industry trade association.
Because of the small number of freshcut processors, the agency is able to
extrapolate data from industry programs
to calculate the total estimated upper
bound burdens that may result from the
issuance of this draft final fresh-cut
guidance (see table 1 of this document).
The burden to industry of developing
and maintaining the activities
recommended in FDA’s draft final freshcut guidance will vary considerably
among fresh-cut processors, depending
on the type and number of products
involved, the sophistication of the
equipment or instruments (e.g., those
that automatically monitor and record
food safety controls), and the type of
E:\FR\FM\13MRN1.SGM
13MRN1
11366
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices
controls monitored under any
individual preventive control program,
such as critical control points (CCPs)
monitored under a hazard analysis and
critical control point (HACCP) program.
Currently, the fresh-cut trade
association estimates that there are 250
fresh-cut plants in operation in the
United States. While most of the recent
growth in the fresh-cut industry has
been due to mergers between already
existing firms, there are approximately
50 fresh-cut plants that did not exist in
2001. This implies that about 10 new
firms are entering the fresh-cut industry
each year. Many of the existing firms in
the fresh-cut industry already make use
of CGMP-related, recall, HACCP, and
other activities. FDA estimates that the
burden of this draft final fresh-cut
guidance will fall on both existing and
new firms entering the industry who
may follow the recommendations in the
guidance.
cprice-sewell on PROD1PC66 with NOTICES
B. SOPs and SSOPs
Two general recommendations in this
draft final guidance are for operators to
develop and implement both a written
standard operating procedures (SOPs)
plan and a written sanitary standard
operation procedures (SSOPs) plan.
SOPs describe in writing the
performance of the day-to-day
operations of a processing plant.
Examples of activities that would fall
under SOPs would be developing
written specifications for agricultural
inputs, ingredients, and packaging
materials; production steps for the
processing and packaging operations;
instructions for packaging and storage
activities; and procedures for equipment
maintenance, calibration, and
replacement and facility maintenance
and upkeep; and maintaining SOP
records on product processing and
distribution activities.
SSOPs provide written instructions or
procedures for sanitary practices
developed for each specific sanitation
activity in and around the facility.
Sanitation activities include procedures
for cleaning equipment, food-contact
surfaces and plant facilities; chemical
use and storage; cleaning equipment
maintenance, use, and storage; pest
control; and maintaining SSOP records
for the activities. From communication
with the fresh-cut industry, we know
that existing fresh-cut processors
already have developed SOPs and
SSOPs. We therefore consider the
development of SOPs and SSOPs to be
‘‘usual and customary’’ for
manufacturers and processors in the
fresh-cut industry (see 5 CFR
1320.3(b)(2)). Thus, we do not calculate
VerDate Aug<31>2005
14:58 Mar 12, 2007
Jkt 211001
this burden for existing firms or new
firms entering this industry.
FDA recommends that facilities not
only develop but also maintain SOPs
and SSOPs. Implementation and
maintenance of SOPs and SSOPs
include maintaining daily records for
each of the firm’s operational days for
the following activities: Inspection of
incoming ingredients, such as the fresh
produce and packaging material; facility
and production sanitation inspections;
equipment maintenance, sanitation, and
visual safety inspections; equipment
calibration, e.g., checking pH meters;
facility and premises pest control
audits; temperature controls during
processing and in storage areas; and
audits of ingredients, food contact
surfaces, and equipment for
microbiological contamination.
Of the 250 fresh-cut processors, the
fresh-cut trade association estimates that
well over half have SOP and SSOP
maintenance programs in place.
Therefore, for purposes of estimating the
annual recordkeeping burden for SOP
and SSOP maintenance programs, the
agency assumed that 40 percent of the
existing processors, or 100 firms, and
the 10 new firms do not have SOP and
SSOP maintenance programs in place.
FDA estimates the recordkeeping
burden for SOP and SSOP maintenance
programs by assuming that these 110
firms will choose to implement such a
maintenance strategy as a result of the
recommendations in this draft final
fresh-cut guidance document, when
finalized.
A typical fresh-cut processing plant
operates about 255 days per year. For an
8–hour shift, assuming the ingredients
are received twice during that time,
under the recommendations in the draft
final guidance, there would be about 13
records kept (2 for inspecting incoming
ingredients; 2 for inspecting the facility
and production areas once every 4
hours; 3 records for equipment
(maintenance, sanitation, and visual
inspections for defects); one for
calibrating equipment; 2 temperature
recording audits (1 time for each of the
2 processing runs); and 3
microbiological audits (ingredients, food
contact surfaces, and equipment)).
Therefore, the annual frequency of
recordkeeping for SOPs and SSOPs is
calculated to be 3,315 times (255 x 13)
per year per firm; 110 firms will be
performing these activities to generate a
total 364,650 records (3,315 x 110)
annually, assuming all firms choose to
follow the recommendations on keeping
records.
The total time to record observations
for SOP and SSOP maintenance is
estimated to take 4 minutes or 0.067
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
hours per record, and the number of
records maintained is 364,650.
Therefore, the total annual burden in
hours for 110 processors to maintain
their SOP and SSOP records is
approximately 24,432 hours. The
maintenance burden for these 110 firms,
along with the annual maintenance
burden of audits or testing, is estimated
in row 1 of table 1 of this document.
Again, these figures assume that all
firms choose to follow the
recommendations on recording
observations.
C. Recall and Traceback
We recommend that fresh-cut
processors establish and maintain
written traceback procedures to respond
to food safety hazard problems when
they arise and establish and maintain a
written contingency plan for use in
initiating and effecting a recall. In order
to facilitate tracebacks and recalls, we
recommend that processors establish a
program that documents and tracks
fresh-cut products back to the source of
their raw ingredients, and keep records
of product identity and specifications,
the product in inventory, and where,
when, to whom, and how much of the
product is shipped.
Traceback programs are used for those
times when a food safety problem has
been identified or a product has been
implicated in a foodborne illness
outbreak. The burden to develop a
traceback program is a one-time activity
estimated to take approximately 20
hours. Firms in the industry may choose
to begin a traceback program after this
guidance is made available. The total
annual estimated burden for this
activity for the 250 existing fresh cut
firms and the 10 new businesses
expected to enter the industry annually
is 5,200 hours. The burden estimate of
developing a traceback program is
shown in row 2 of table 1 of this
document.
Traceback program adjustments or
revisions may, or may not, be needed
annually. Firms may test their traceback
programs yearly to see if adjustments
are needed to maintain traceback
capabilities. Evaluating and updating
traceback programs is estimated to take
40 hours to complete. The annual
burden of maintaining a traceback
program is estimated for the 250
existing firms in the industry plus the
10 firms new to the industry that may
decide to implement this type of
program. Assuming that each firm
completes this exercise once a year, the
total maintenance burden of traceback
programs is 10,400 hours yearly. This
burden estimate is shown in row 3 of
table 1 of this document.
E:\FR\FM\13MRN1.SGM
13MRN1
11367
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices
This draft final fresh-cut guidance
refers to previously approved
collections of information found in FDA
regulations. The recommendations in
this document regarding establishing
and maintaining a recall plan, as
provided in 21 CFR 7.59, have been
approved under OMB control number
0910–0249. Therefore, FDA is not
calculating a new paperwork burden for
recall plans.
D. Preventative Control Program
When properly designed and
maintained by the establishment’s
personnel, a preventive control program
is a valuable program for managing the
safety of food products. A common
preventive control program used by the
fresh-cut industry is a HACCP system. A
HACCP system allows managers to
assess the inherent risks and identify
hazards attributable to a product or a
process, and then determine the
necessary steps to control the hazards.
Monitoring and verification steps,
which include recordkeeping, are
included in the HACCP system to
ensure that potential risks are
controlled. We use HACCP as an
example of a preventive control program
that a firm may choose based on the
recommendations in the draft final
guidance to estimate the burden of
developing, implementing, and
reviewing a preventive control program.
FDA estimated the paperwork burden
of developing and implementing a
HACCP plan based on a plan with two
CCPs. The number of CCPs may vary
depending on how the processor
chooses to identify the CCPs for a
particular operation. Of the estimated
250 fresh-cut processors, the fresh-cut
industry estimates that approximately
50 percent of the firms already have
HACCP plans in place. Therefore,
assuming that the remaining fresh-cut
processors voluntarily decide to develop
a HACCP plan, 125 existing firms plus
the 10 new firms, will develop a HACCP
plan.
Developing a HACCP plan is a onetime activity that is estimated to take
100 hours based on a trained HACCP
team working on the plan full time. The
HACCP team identifies the CCPs and
measures needed to control them, and
then identifies the approach needed to
verify the effectiveness of the controls.
During this plan development period,
the firm chooses the records to be kept
and information and observations to be
recorded. This is a one-time process
during the first year. Therefore, the total
time for 135 processors to develop their
individual HACCP plans is
approximately 13,500 hours. This onetime burden is shown in row 4 of table
1 of this document.
After the HACCP plan is developed,
the frequency for recordkeeping for
implementing or maintaining daily
records is estimated to be 510 records
per year. (This is based on a firm
choosing to maintain daily records for 2
CCPs for one 8–hour shift per day for
each of the estimated 255 operational
days per year.) The total time to record
observations for the CCPs was estimated
to take 4 minutes or 0.067 hours per
record. Therefore, the total annual
records kept by the 135 firms choosing
to implement the HACCP plan is 68,850,
and the ‘‘Total Hours’’ required are
4,613. This annual burden is shown in
row 5 of table 1 of this document.
After the HACCP plan has been
developed and implemented, we
recommend that the plan is reviewed
regularly to ensure that it is working
properly. Fresh-cut processors are
estimated to review their HACCP plans
four times per year (once per quarter).
Assuming that it takes each of the 135
firms 4 hours per review each quarter,
the total burden of this activity, for
firms that choose to review their plans
annually, is 2,160 hours per year. This
annual burden is shown in row 6 of
table 1 of this document.
FDA estimates the burden of the
collection of information described in
the previous paragraphs as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Activity
Annual Frequency
per
Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
SOP and SSOP: Maintenance
110
3,315
364,650
0.067
24,432
Traceback Development2
260
1
260
20
5,200
Traceback Maintenance
260
1
260
40
10,400
Preventive control program comparable to a HACCP system:
System development2
135
1
135
100
13,500
Preventive control program comparable to a HACCP system:
System implementation
135
510
68,850
0.067
4,613
Preventive control program comparable to a HACCP system:
Implementation review
135
4
540
4
2,160
18,700
Annual burden hours
cprice-sewell on PROD1PC66 with NOTICES
One-time burden hours
41,605
1 There
2 First
are no capital costs or operating and maintenance costs associated with this collection of information.
year activity.
Summing the ‘‘Total Hours’’ column,
the estimated one-time recordkeeping
burden for firms that choose to follow
the recommendations is 18,700 hours;
VerDate Aug<31>2005
14:58 Mar 12, 2007
Jkt 211001
the annual burden for firms, existing
and new, is estimated to be 41,605
hours.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
III. Comments
Interested persons may submit written
or electronic comments to the Division
E:\FR\FM\13MRN1.SGM
13MRN1
11368
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices
of Dockets Management (see ADDRESSES)
regarding this guidance document at
any time. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The draft final guidance and
received comments may be seen in the
office above between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft final guidance
document at https://www.cfsan.fda.gov/
~dms/guidance.html.
Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–4446 Filed 3–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0073]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Control of
Communicable Diseases; Restrictions
on African Rodents, Prairie Dogs, and
Certain Other Animals
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
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 collection requirements
establishing restrictions on the import,
capture, transport, sale, barter,
exchange, distribution, and release of
African rodents, prairie dogs, and
certain other animals.
DATES: Submit written or electronic
comments on the collection of
information by May 14, 2007.
ADDRESSES: Submit electronic
comments on the collection of
VerDate Aug<31>2005
14:58 Mar 12, 2007
Jkt 211001
information to: https://www.fda.gov/
dockets/ecomments. 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–827–
4659.
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.
SUPPLEMENTARY INFORMATION:
Control of Communicable Diseases;
African Rodents and Other Animals
That May Carry the Monkeypox
Virus—21 CFR 1240.63 (OMB Control
Number 0910–0519)—Extension
Under 21 CFR 1240.63(a)(2)(ii), an
individual must submit a written
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
request to seek permission to capture,
offer to capture, transport, offer to
transport, sell, barter, or exchange, offer
to sell, barter, or exchange, distribute,
offer to distribute, and/or release into
the environment any of the following
animals:
• Prairie dogs (Cynomys sp.),
• African Tree squirrels (Heliosciurus
sp.),
• Rope squirrels (Funisciurus sp.),
• African Dormice (Graphiurus sp.),
• Gambian giant pouched rats
(Cricetomys sp.),
• Brush-tailed porcupines (Atherurus
sp.),
• Striped mice (Hybomys sp.), or
• Any other animal so prohibited by
order of the Commissioner of Food and
Drugs (the Commissioner) because of
that animal’s potential to transmit the
monkeypox virus.
The request cannot seek written
permission to sell, barter, or exchange,
or offer to sell, barter, or exchange, as
a pet, the animals listed previously or
any animal covered by an order by the
Commissioner.
The request must state the reasons
why an exemption is needed, describe
the animals involved, and explain why
an exemption will not result in the
spread of monkeypox within the United
States.
Our estimates are based on our
current experience with the interim
final rule. To estimate the number of
respondents, we examined the number
of requests we have received in fiscal
year 2006. There were 122 requests,
submitted by 65 individuals, in that
time, and this figure represents a minor
increase over the previous estimate of
120 annual responses. (See 69 FR 7752
(February 19, 2004).) As we cannot
determine whether the latest data
indicates a trend towards more requests
or is an anomaly, we have elected to
increase our estimate to 122 requests.
We also have revised the estimated
number of respondents to 65 (compared
to 120 in our previous estimate) and, as
a result, adjusted the annual frequency
per response to 1.88 (which represents
122 responses/65 respondents; the
actual result is 1.8769, which we have
rounded up to 1.88).
Furthermore, consistent with our
earlier Paperwork Reduction Act
submission, we will estimate that each
respondent will need 4 hours to
complete its request for an exemption.
Therefore, the total reporting burden
under 21 CFR 1240.63(a)(2)(ii)(A) and
(B) will be 488 hours (122 responses x
4 hours per response = 488 hours).
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 72, Number 48 (Tuesday, March 13, 2007)]
[Notices]
[Pages 11364-11368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4446]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0079]
Draft Final Guidance for Industry: Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency
Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft final guidance document entitled ``Guidance for
Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut
Fruits and Vegetables'' (the draft final fresh-cut guidance). This
document complements FDA's Current Good Manufacturing Practice (CGMP)
requirements for foods by providing specific guidance on the processing
of fresh-cut produce. The draft final fresh-cut guidance and the CGMP
regulations are intended to assist processors in minimizing microbial
food safety hazards common to the processing of most fresh-cut fruits
and vegetables sold to consumers and retail establishments in a ready-
to-eat form. FDA also 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 (the PRA).
DATES: Submit written or electronic comments on the guidance at any
time. Fax written comments on the collection of information by April
12, 2007.
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: 202-395-6974. Submit written requests for single copies of the
draft final guidance entitled: ``Guidance for Industry: Guide to
Minimize Microbial Food Safety Hazards for Fresh-Cut Fruits and
Vegetables'' to the Center for Food Safety and Applied Nutrition,
Office of Plant and Dairy Foods (HFS-306), 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-436-1400 or FAX: 301-436-2651. Include a
self-addressed adhesive label to assist that office in processing your
request.
Submit written comments on the draft final guidance, identified
with Docket
[[Page 11365]]
No. 2006D-0079, to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance. A copy of the draft final guidance is available
for public examination in the Division of Dockets Management, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with access to the Internet may obtain
the draft final guidance at https://www.cfsan.fda.gov/~dms/
guidance.html.
FOR FURTHER INFORMATION CONTACT:
With regard to the information collection: Jonna Capezzuto, Office
of the Chief Information Officer (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
With regard to the draft final guidance document: Amy Green, Center
for Food Safety and Applied Nutrition (HFS-306), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2025 or FAX: 301-436-2651, e-mail: amy.green@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Fresh-cut fruits and vegetables are minimally processed fruits and
vegetables that have been altered in form by peeling, slicing,
chopping, shredding, coring, or trimming, with or without washing or
other treatment, prior to being packaged for use by the consumer or a
retail establishment. The methods by which produce is grown, harvested,
and processed may contribute to its contamination with pathogens and,
consequently, the role of the produce in transmitting foodborne
illness. Factors such as the high degree of handling and mixing of the
product, the release of cellular fluids during cutting or chopping, the
high moisture content of the product, the absence of a step lethal to
pathogens, and the potential for temperature abuse in the processing,
storage, transport, and retail display all enhance the potential for
pathogens to survive and grow in fresh-cut produce.
With this notice, FDA is announcing the availability of the draft
final fresh-cut guidance. The draft final fresh-cut guidance is
intended to assist processors in minimizing microbial food safety
hazards common to the processing of most fresh-cut fruits and
vegetables sold to consumers in a ready-to-eat form. The draft final
guidance was revised based on public comments. This draft final
guidance represents FDA's current thinking on the microbiological
hazards presented by most fresh-cut fruits and vegetables and the
recommended control measures for such hazards in the processing of such
produce. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. You may use an
alternative approach if such approach satisfies the requirements of the
applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).
II. Paperwork Reduction Act of 1995
This draft final guidance contains information collection
provisions that are subject to review by the OMB under the PRA (44
U.S.C 3501-3520). Under the PRA, Federal agencies must obtain approval
from 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 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 before
submitting the collection to OMB for approval. To comply with this
requirement, in the Federal Register of March 6, 2006 (71 FR 11209),
FDA gave interested persons 60 days to comment on the information
collection provisions in the draft guidance. FDA received a number of
comments on the draft guidance but received no comments regarding the
information collection provisions.
After publishing the 60-day notice requesting public comment,
section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to
submit the proposed collection to OMB for review and clearance. In
compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance. FDA
will not finalize this guidance unless and until OMB approves the
collection of information. If the collection is approved, FDA will
publish a notice in the Federal Register announcing that the guidance
is final and providing an OMB control number.
Draft Final Guidance for Industry: Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and Vegetables
Description: The Federal Food, Drug, and Cosmetic Act (the act)
prohibits the distribution of adulterated food in interstate commerce
(21 U.S.C. 331 and 342). In response to the increased consumption of
fresh-cut fruits and vegetables and the potential for foodborne illness
associated with these products, FDA recognizes the need for guidance
specific to the processing of fresh-cut fruits and vegetables.
Accordingly, FDA encourages fresh-cut produce processors to adopt the
general recommendations in the guidance and to tailor practices to
their individual operations.
FDA's draft final fresh-cut guidance represents the agency's
recommendations to industry based on the current state of science.
Following the recommendations set forth in the fresh-cut guidance is
the choice of each individual fresh-cut operation, plant, or processor.
FDA estimates the burden of this guidance on industry by assuming that
those in the fresh-cut industry who do not currently follow the
recommendations put forth in the guidance will find it of value to do
so. Therefore, the estimates of the burden associated with the issuance
of this guidance represent the upper bound estimate of burden, the
burden if every fresh-cut plant, processor, or operation that does not
follow the recommendations of the guidance should choose to do so.
A. Industry Profile
Estimates of the paperwork burden to the fresh-cut industry that
may result from the publication of FDA's draft final fresh-cut guidance
are based on information from FDA's relationship with a fresh-cut
processor who has developed and maintained these programs and
information from a fresh-cut produce industry trade association.
Because of the small number of fresh-cut processors, the agency is able
to extrapolate data from industry programs to calculate the total
estimated upper bound burdens that may result from the issuance of this
draft final fresh-cut guidance (see table 1 of this document).
The burden to industry of developing and maintaining the activities
recommended in FDA's draft final fresh-cut guidance will vary
considerably among fresh-cut processors, depending on the type and
number of products involved, the sophistication of the equipment or
instruments (e.g., those that automatically monitor and record food
safety controls), and the type of
[[Page 11366]]
controls monitored under any individual preventive control program,
such as critical control points (CCPs) monitored under a hazard
analysis and critical control point (HACCP) program.
Currently, the fresh-cut trade association estimates that there are
250 fresh-cut plants in operation in the United States. While most of
the recent growth in the fresh-cut industry has been due to mergers
between already existing firms, there are approximately 50 fresh-cut
plants that did not exist in 2001. This implies that about 10 new firms
are entering the fresh-cut industry each year. Many of the existing
firms in the fresh-cut industry already make use of CGMP-related,
recall, HACCP, and other activities. FDA estimates that the burden of
this draft final fresh-cut guidance will fall on both existing and new
firms entering the industry who may follow the recommendations in the
guidance.
B. SOPs and SSOPs
Two general recommendations in this draft final guidance are for
operators to develop and implement both a written standard operating
procedures (SOPs) plan and a written sanitary standard operation
procedures (SSOPs) plan. SOPs describe in writing the performance of
the day-to-day operations of a processing plant. Examples of activities
that would fall under SOPs would be developing written specifications
for agricultural inputs, ingredients, and packaging materials;
production steps for the processing and packaging operations;
instructions for packaging and storage activities; and procedures for
equipment maintenance, calibration, and replacement and facility
maintenance and upkeep; and maintaining SOP records on product
processing and distribution activities.
SSOPs provide written instructions or procedures for sanitary
practices developed for each specific sanitation activity in and around
the facility. Sanitation activities include procedures for cleaning
equipment, food-contact surfaces and plant facilities; chemical use and
storage; cleaning equipment maintenance, use, and storage; pest
control; and maintaining SSOP records for the activities. From
communication with the fresh-cut industry, we know that existing fresh-
cut processors already have developed SOPs and SSOPs. We therefore
consider the development of SOPs and SSOPs to be ``usual and
customary'' for manufacturers and processors in the fresh-cut industry
(see 5 CFR 1320.3(b)(2)). Thus, we do not calculate this burden for
existing firms or new firms entering this industry.
FDA recommends that facilities not only develop but also maintain
SOPs and SSOPs. Implementation and maintenance of SOPs and SSOPs
include maintaining daily records for each of the firm's operational
days for the following activities: Inspection of incoming ingredients,
such as the fresh produce and packaging material; facility and
production sanitation inspections; equipment maintenance, sanitation,
and visual safety inspections; equipment calibration, e.g., checking pH
meters; facility and premises pest control audits; temperature controls
during processing and in storage areas; and audits of ingredients, food
contact surfaces, and equipment for microbiological contamination.
Of the 250 fresh-cut processors, the fresh-cut trade association
estimates that well over half have SOP and SSOP maintenance programs in
place. Therefore, for purposes of estimating the annual recordkeeping
burden for SOP and SSOP maintenance programs, the agency assumed that
40 percent of the existing processors, or 100 firms, and the 10 new
firms do not have SOP and SSOP maintenance programs in place. FDA
estimates the recordkeeping burden for SOP and SSOP maintenance
programs by assuming that these 110 firms will choose to implement such
a maintenance strategy as a result of the recommendations in this draft
final fresh-cut guidance document, when finalized.
A typical fresh-cut processing plant operates about 255 days per
year. For an 8-hour shift, assuming the ingredients are received twice
during that time, under the recommendations in the draft final
guidance, there would be about 13 records kept (2 for inspecting
incoming ingredients; 2 for inspecting the facility and production
areas once every 4 hours; 3 records for equipment (maintenance,
sanitation, and visual inspections for defects); one for calibrating
equipment; 2 temperature recording audits (1 time for each of the 2
processing runs); and 3 microbiological audits (ingredients, food
contact surfaces, and equipment)). Therefore, the annual frequency of
recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x
13) per year per firm; 110 firms will be performing these activities to
generate a total 364,650 records (3,315 x 110) annually, assuming all
firms choose to follow the recommendations on keeping records.
The total time to record observations for SOP and SSOP maintenance
is estimated to take 4 minutes or 0.067 hours per record, and the
number of records maintained is 364,650. Therefore, the total annual
burden in hours for 110 processors to maintain their SOP and SSOP
records is approximately 24,432 hours. The maintenance burden for these
110 firms, along with the annual maintenance burden of audits or
testing, is estimated in row 1 of table 1 of this document. Again,
these figures assume that all firms choose to follow the
recommendations on recording observations.
C. Recall and Traceback
We recommend that fresh-cut processors establish and maintain
written traceback procedures to respond to food safety hazard problems
when they arise and establish and maintain a written contingency plan
for use in initiating and effecting a recall. In order to facilitate
tracebacks and recalls, we recommend that processors establish a
program that documents and tracks fresh-cut products back to the source
of their raw ingredients, and keep records of product identity and
specifications, the product in inventory, and where, when, to whom, and
how much of the product is shipped.
Traceback programs are used for those times when a food safety
problem has been identified or a product has been implicated in a
foodborne illness outbreak. The burden to develop a traceback program
is a one-time activity estimated to take approximately 20 hours. Firms
in the industry may choose to begin a traceback program after this
guidance is made available. The total annual estimated burden for this
activity for the 250 existing fresh cut firms and the 10 new businesses
expected to enter the industry annually is 5,200 hours. The burden
estimate of developing a traceback program is shown in row 2 of table 1
of this document.
Traceback program adjustments or revisions may, or may not, be
needed annually. Firms may test their traceback programs yearly to see
if adjustments are needed to maintain traceback capabilities.
Evaluating and updating traceback programs is estimated to take 40
hours to complete. The annual burden of maintaining a traceback program
is estimated for the 250 existing firms in the industry plus the 10
firms new to the industry that may decide to implement this type of
program. Assuming that each firm completes this exercise once a year,
the total maintenance burden of traceback programs is 10,400 hours
yearly. This burden estimate is shown in row 3 of table 1 of this
document.
[[Page 11367]]
This draft final fresh-cut guidance refers to previously approved
collections of information found in FDA regulations. The
recommendations in this document regarding establishing and maintaining
a recall plan, as provided in 21 CFR 7.59, have been approved under OMB
control number 0910-0249. Therefore, FDA is not calculating a new
paperwork burden for recall plans.
D. Preventative Control Program
When properly designed and maintained by the establishment's
personnel, a preventive control program is a valuable program for
managing the safety of food products. A common preventive control
program used by the fresh-cut industry is a HACCP system. A HACCP
system allows managers to assess the inherent risks and identify
hazards attributable to a product or a process, and then determine the
necessary steps to control the hazards. Monitoring and verification
steps, which include recordkeeping, are included in the HACCP system to
ensure that potential risks are controlled. We use HACCP as an example
of a preventive control program that a firm may choose based on the
recommendations in the draft final guidance to estimate the burden of
developing, implementing, and reviewing a preventive control program.
FDA estimated the paperwork burden of developing and implementing a
HACCP plan based on a plan with two CCPs. The number of CCPs may vary
depending on how the processor chooses to identify the CCPs for a
particular operation. Of the estimated 250 fresh-cut processors, the
fresh-cut industry estimates that approximately 50 percent of the firms
already have HACCP plans in place. Therefore, assuming that the
remaining fresh-cut processors voluntarily decide to develop a HACCP
plan, 125 existing firms plus the 10 new firms, will develop a HACCP
plan.
Developing a HACCP plan is a one-time activity that is estimated to
take 100 hours based on a trained HACCP team working on the plan full
time. The HACCP team identifies the CCPs and measures needed to control
them, and then identifies the approach needed to verify the
effectiveness of the controls. During this plan development period, the
firm chooses the records to be kept and information and observations to
be recorded. This is a one-time process during the first year.
Therefore, the total time for 135 processors to develop their
individual HACCP plans is approximately 13,500 hours. This one-time
burden is shown in row 4 of table 1 of this document.
After the HACCP plan is developed, the frequency for recordkeeping
for implementing or maintaining daily records is estimated to be 510
records per year. (This is based on a firm choosing to maintain daily
records for 2 CCPs for one 8-hour shift per day for each of the
estimated 255 operational days per year.) The total time to record
observations for the CCPs was estimated to take 4 minutes or 0.067
hours per record. Therefore, the total annual records kept by the 135
firms choosing to implement the HACCP plan is 68,850, and the ``Total
Hours'' required are 4,613. This annual burden is shown in row 5 of
table 1 of this document.
After the HACCP plan has been developed and implemented, we
recommend that the plan is reviewed regularly to ensure that it is
working properly. Fresh-cut processors are estimated to review their
HACCP plans four times per year (once per quarter). Assuming that it
takes each of the 135 firms 4 hours per review each quarter, the total
burden of this activity, for firms that choose to review their plans
annually, is 2,160 hours per year. This annual burden is shown in row 6
of table 1 of this document.
FDA estimates the burden of the collection of information described
in the previous paragraphs as follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency
Activity No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
----------------------------------------------------------------------------------------------------------------
SOP and SSOP: 110 3,315 364,650 0.067 24,432
Maintenance
----------------------------------------------------------------------------------------------------------------
Traceback 260 1 260 20 5,200
Development\2\
----------------------------------------------------------------------------------------------------------------
Traceback 260 1 260 40 10,400
Maintenance
----------------------------------------------------------------------------------------------------------------
Preventive 135 1 135 100 13,500
control program
comparable to a
HACCP system:
System
development\2\
----------------------------------------------------------------------------------------------------------------
Preventive 135 510 68,850 0.067 4,613
control program
comparable to a
HACCP system:
System
implementation
----------------------------------------------------------------------------------------------------------------
Preventive 135 4 540 4 2,160
control program
comparable to a
HACCP system:
Implementation
review
----------------------------------------------------------------------------------------------------------------
One-time burden ................. ................. ................. ................. 18,700
hours
----------------------------------------------------------------------------------------------------------------
Annual burden hours 41,605
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ First year activity.
Summing the ``Total Hours'' column, the estimated one-time
recordkeeping burden for firms that choose to follow the
recommendations is 18,700 hours; the annual burden for firms, existing
and new, is estimated to be 41,605 hours.
III. Comments
Interested persons may submit written or electronic comments to the
Division
[[Page 11368]]
of Dockets Management (see ADDRESSES) regarding this guidance document
at any time. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. The draft final guidance
and received comments may be seen in the office above between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft final
guidance document at https://www.cfsan.fda.gov/~dms/guidance.html.
Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4446 Filed 3-12-07; 8:45 am]
BILLING CODE 4160-01-S
