Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 56154-56156 [E6-15694]
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56154
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
with this provision is approved under
OMB control number 0910–0437.
Respondents to this collection of
information are manufacturers of in
vitro diagnostic devices.
In the Federal Register of September
7, 2005 (70 FR 53231), FDA solicited
comments on the collection of
information requirements. No comments
were received in response to this notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No of Respondents
Annual Frequency
per Response
40
Total Annual Responses
1
1There
Hours per
Response
40
Total Hours
780
31,200
Total Operating &
Maintenance
Costs
$5,500
are no capital costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency
per Recordkeeper
40
1There
1
Hours per Record
40
Total Hours
2,800
112,000
Total Operating &
Maintenance
Costs
$60,700
are no capital costs associated with this collection of information.
Based on previous years of
experience, with CLIA waiver
applications, FDA expects 40
manufacturers to apply for one CLIA
waiver per year. The annual reporting
burden to respondents is estimated to be
31,200 hours and the recordkeeping
burden for respondents is estimated to
be 112,00 hours. FDA based the
reporting and recordkeeping burden on
agency analysis of premarket
submissions with clinical trials similar
to the waived laboratory tests.
The total operating and maintenance
costs associated with the
implementation of this draft guidance is
estimated to be $66,200. The cost
consists of specimen collections for the
clinical study (estimated at $23,500);
laboratory supplies, reference testing,
and study oversight (estimated at
$26,700); shipping and office supplies
(estimated at $6,000); and educational
materials, including quick reference
instructions (estimated at $10,000).
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–15693 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
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Total Annual
Records
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0357]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
extending OMB approval on the existing
reporting and recordkeeping
requirements for processors and
importers of fish and fishery products.
DATES: Submit written or electronic
comments on the collection of
information by November 27, 2006.
ADDRESSES: Submit electronic
comments on the collection of
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
PO 00000
Frm 00055
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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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60–day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
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26SEN1
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
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.
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—21 CFR Part 123
(OMB Control Number 0910–0354)—
Extension
FDA regulations in part 123 (21 CFR
part 123) mandate the application of
hazard analysis and critical control
point (HACCP) principles to the
processing of seafood. HACCP is a
preventive system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety, including section
402(a)(1) and (a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (a)(4)), and became
effective on December 18, 1997.
Certain provisions in part 123 require
that processors and importers of seafood
collect and record information. The
HACCP records compiled and
maintained by a seafood processor
primarily consist of the periodic
observations recorded at selected
monitoring points during processing
and packaging operations, as called for
in a processor’s HACCP plan (e.g., the
values for processing times,
temperatures, acidity, etc., as observed
at critical control points). The primary
purpose of HACCP records is to permit
a processor to verify that products have
been produced within carefully
established processing parameters
(critical limits) that ensure that hazards
have been avoided. HACCP records are
normally reviewed by appropriately
trained employees at the end of a
production lot or at the end of a day or
week of production to verify that control
limits have been maintained, or that
appropriate corrective actions were
taken if the critical limits were not
maintained. Such verification activities
are essential to ensure that the HACCP
system is working as planned. A review
of these records during the conduct of
periodic plant inspections also permits
FDA to determine whether the products
have been consistently processed in
conformance with appropriate HACCP
food safety controls.
Section 123.12 requires that importers
of seafood products take affirmative
steps and maintain records that verify
that the fish and fishery products they
offer for import into the United States
were processed in accordance with the
HACCP and sanitation provisions set
forth in part 123. These records are also
56155
to be made available for review by FDA
as provided in § 123.12(c).
The time and costs of these
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the type and number of
products involved, and on the nature of
the equipment or instruments required
to monitor critical control points. The
burdens have been estimated using
typical small seafood processing firms
as a model because these firms represent
a significant proportion of the industry.
Costs were estimated for the collection
of HACCP data for each type of
recordkeeping activity using a labor cost
of $15.00 per hour.
The burden estimate in table 1 of this
document includes only those
collections of information under the
seafood HACCP regulations that are not
already required under other statutes
and regulations. The estimate also does
not include collections of information
that are a usual and customary part of
businesses’ normal activities. For
example, the tagging and labeling of
molluscan shellfish (21 CFR 1240.60) is
a customary and usual practice among
seafood processors. Consequently, the
estimates in table 1 account only for
information collection and recording
requirements attributable to part 123.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section2
No. of
Respondents
123.6(a),(b), and (c)
Annual Frequency per
Response3
Total Annual
Responses
Hours per
Response4
Total Hours
275
1
275
16.00
4,400
123.6(c)(5)
5,500
4
22,000
0.30
6,600
123.8(a)(1) and (c)
5,500
1
5,500
4.00
22,000
123.12(a)(2)(ii)
1,100
80
88,000
0.20
17,600
123.6(c)(7)
5,500
280
1,540,000
0.30
462,000
123.7(d)
2,200
4
8800
0.10
880
123.8(d)
5,500
47
258,500
0.10
25,850
123.11(c)
5,500
280
1,540,000
0.10
154,000
123.12(c)
1,100
80
88,000
0.10
8,800
55
1
55
4.00
220
275
1
275
24.00
6,600
123.12(a)(2)
123.10
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Total
708,950
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates include the information collection requirements in the following sections:§ 123.16Smoked Fish—process controls (see
§ 123.6(b))§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b))§ 123.28(c) and (d)—Records—molluscan shellfish (see
§ 123.6(c)(7))
3Based on an estimated 280 working days per year.
3Based on an estimated 280 working days per year.
4Estimated average time per 8-hour work day unless one-time response.
2These
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56156
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
Dated: September 19, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–15694 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0427]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KETEK
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PRODPC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for KETEK
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent that claims that
human drug product.
ADDRESSES: Submit written comments
and petitions 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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
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21:03 Sep 25, 2006
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product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the product. Although only a portion of
a regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product KETEK
(telithromycin). KETEK is indicated for
treatment of acute bacterial exacerbation
of chronic bronchitis due to
Streptococcus (S.) pneumoniae,
Haemophilus (H.) influenzae, or
Moraxella (M.) catarrhalis, acute
bacterial sinusitis due to S.
pneumoniae, H. influenzae, M.
catarrhalis, or Staphylococcus aureus,
and community-acquired pneumonia
due to S. pneumoniae, H. influenzae, M.
catarrhalis, Chlamydophila
pneumoniae, or Mycoplasma
pneumoniae, for patients 18 years old
and above. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for KETEK (U.S. Patent No.
5,635,485) from Aventis S. A., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated March 29,
2006, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
KETEK represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
KETEK is 2,206 days. Of this time, 713
days occurred during the testing phase
of the regulatory review period, while
1,493 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: March 20,
1998. The applicant claims February 19,
1998, as the date the investigational new
PO 00000
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drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was March 20, 1998,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: March 1, 2000. The
applicant claims February 28, 2000, as
the date the new drug application
(NDA) for Ketek (NDA 21–144) was
initially submitted. However, FDA
records indicate that NDA 21–144 was
submitted on March 1, 2000.
3. The date the application was
approved: April 1, 2004. FDA has
verified the applicant’s claim that NDA
21–144 was approved on April 1, 2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,076 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by November 27, 2006.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 26, 2007. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–15690 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56154-56156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15694]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0357]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on extending OMB approval on the
existing reporting and recordkeeping requirements for processors and
importers of fish and fishery products.
DATES: Submit written or electronic comments on the collection of
information by November 27, 2006.
ADDRESSES: Submit electronic comments on the collection of 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the
[[Page 56155]]
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.
Procedures for the Safe and Sanitary Processing and Importing of Fish
and Fishery Products--21 CFR Part 123 (OMB Control Number 0910-0354)--
Extension
FDA regulations in part 123 (21 CFR part 123) mandate the
application of hazard analysis and critical control point (HACCP)
principles to the processing of seafood. HACCP is a preventive system
of hazard control designed to help ensure the safety of foods. The
regulations were issued under FDA's statutory authority to regulate
food safety, including section 402(a)(1) and (a)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and
became effective on December 18, 1997.
Certain provisions in part 123 require that processors and
importers of seafood collect and record information. The HACCP records
compiled and maintained by a seafood processor primarily consist of the
periodic observations recorded at selected monitoring points during
processing and packaging operations, as called for in a processor's
HACCP plan (e.g., the values for processing times, temperatures,
acidity, etc., as observed at critical control points). The primary
purpose of HACCP records is to permit a processor to verify that
products have been produced within carefully established processing
parameters (critical limits) that ensure that hazards have been
avoided. HACCP records are normally reviewed by appropriately trained
employees at the end of a production lot or at the end of a day or week
of production to verify that control limits have been maintained, or
that appropriate corrective actions were taken if the critical limits
were not maintained. Such verification activities are essential to
ensure that the HACCP system is working as planned. A review of these
records during the conduct of periodic plant inspections also permits
FDA to determine whether the products have been consistently processed
in conformance with appropriate HACCP food safety controls.
Section 123.12 requires that importers of seafood products take
affirmative steps and maintain records that verify that the fish and
fishery products they offer for import into the United States were
processed in accordance with the HACCP and sanitation provisions set
forth in part 123. These records are also to be made available for
review by FDA as provided in Sec. 123.12(c).
The time and costs of these recordkeeping activities will vary
considerably among processors and importers of fish and fishery
products, depending on the type and number of products involved, and on
the nature of the equipment or instruments required to monitor critical
control points. The burdens have been estimated using typical small
seafood processing firms as a model because these firms represent a
significant proportion of the industry. Costs were estimated for the
collection of HACCP data for each type of recordkeeping activity using
a labor cost of $15.00 per hour.
The burden estimate in table 1 of this document includes only those
collections of information under the seafood HACCP regulations that are
not already required under other statutes and regulations. The estimate
also does not include collections of information that are a usual and
customary part of businesses' normal activities. For example, the
tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a
customary and usual practice among seafood processors. Consequently,
the estimates in table 1 account only for information collection and
recording requirements attributable to part 123.
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
21 CFR Section\2\ Respondents Response\3\ Responses Response\4\ Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a),(b), and (c) 275 1 275 16.00 4,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(5) 5,500 4 22,000 0.30 6,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(a)(1) and (c) 5,500 1 5,500 4.00 22,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2)(ii) 1,100 80 88,000 0.20 17,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(7) 5,500 280 1,540,000 0.30 462,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.7(d) 2,200 4 8800 0.10 880
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(d) 5,500 47 258,500 0.10 25,850
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.11(c) 5,500 280 1,540,000 0.10 154,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(c) 1,100 80 88,000 0.10 8,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2) 55 1 55 4.00 220
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.10 275 1 275 24.00 6,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 708,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\These estimates include the information collection requirements in the following sections:Sec. 123.16Smoked Fish--process controls (see Sec.
123.6(b))Sec. 123.28(a)--Source Controls--molluscan shellfish (see Sec. 123.6(b))Sec. 123.28(c) and (d)--Records--molluscan shellfish (see Sec.
123.6(c)(7))
\3\Based on an estimated 280 working days per year.
\4\Estimated average time per 8-hour work day unless one-time response.
[[Page 56156]]
Dated: September 19, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-15694 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S
