Submission for OMB Review; Comment Request; National Institute of Diabetes and Digestive and Kidney Diseases Information Clearinghouses Customer Satisfaction Survey, 34748-34749 [2010-14793]
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34748
3Based
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
on an estimated 280 working days per year.
average time per 8-hour workday unless one-time response.
srobinson on DSKHWCL6B1PROD with NOTICES
4Estimated
FDA bases this hour burden estimate
on its experience with the application of
HACCP principles in food processing.
Further, the burdens have been
estimated using typical small seafood
processing firms as a model because
these firms represent a significant
proportion of the industry. The hour
burden of HACCP recordkeeping
activities will vary considerably among
processors and importers of fish and
fishery products, depending on the size
of the facility and complexity of the
HACCP control scheme (i.e., the number
of products and the number of hazards
controlled); the daily frequency that
control points are monitored and values
recorded; and also on the extent that
data recording time and cost are
minimized by the use of automated data
logging technology. The burden estimate
does not include burden hours for
activities that are a usual and customary
part of businesses’ normal activities. For
example, the tagging and labeling of
molluscan shellfish (§ 1240.60) is a
customary and usual practice among
seafood processors.
Based on its records, FDA estimates
that there are 15,000 processors and
4,100 importers. FDA estimates that 50
processors will undertake the initial
preparation of a hazard analysis and
HAACP plan (§ 123.6(a),(b), and (c)).
FDA estimates the burden for the initial
preparation of a hazard analysis and
HAACP plan to be 16 hours per
processor for a total burden of 800
hours. FDA estimates that all processors
(15,000 processors) will undertake and
keep records of 4 corrective action plans
(§ 123.6(c)(5)) for a total of 60,000
records. FDA estimates the burden for
the preparation of each record to be 0.30
hours for a total burden of 18,000 hours.
FDA estimates that all processors
(15,000 processors) will annually
reassess their hazard analysis and
HACCP plan (§ 123.8(a)(1) and (c)). FDA
estimates the burden for the
reassessment of the hazard analysis and
HAACP plan to be 4 hours per processor
for a total burden of 60,000 hours.
FDA estimates that all importers
(4,100 importers) will take affirmative
steps to verify compliance of imports
and prepare 80 records of their
verification activities (§ 123.12(a)(2)(ii))
for a total of 328,000 records. FDA
estimates the burden for the preparation
of each record to be 0.20 hours for a
total burden of 65,600 hours.
FDA estimates that all processors
(15,000 processors) will document the
monitoring of critical control points
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18:14 Jun 17, 2010
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(§ 123.6(c)(7)) at 280 records per
processor for a total of 4,200,000
records. FDA estimates the burden for
the preparation of each record to be 0.30
hours for a total burden of 1,260,000
hours.
FDA estimates that 40 percent of all
processors (6,000 processors) will
maintain records of any corrective
actions taken due to a deviation from a
critical limit (§ 123.7(d)) at 4 records per
processor for a total of 24,000 records.
FDA estimates the burden for the
preparation of each record to be 0.10
hours for a total burden of 2,400 hours.
FDA estimates that all processors
(15,000 processors) will maintain
records of the calibration of processmonitoring instruments and the
performing of any periodic end-product
and in-process testing (§ 123.8(d)) at 47
records per processor for a total of
705,000 records. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 70,500 hours.
FDA estimates that all processors
(15,000 processors) will maintain
sanitation control records (§ 123.11(c))
at 280 records per processor for a total
of 4,200,000 records. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 420,000 hours.
FDA estimates that all importers
(4,100 importers) will 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 (§ 123.12(c)). FDA estimates that 80
records will be prepared per importer
for a total of 328,000 records. FDA
estimates the burden for the preparation
of each record to be 0.10 hours for a
total burden of 32,800 hours.
FDA estimates that 1 percent of all
importers (41 importers) will require
new written verification procedures to
verify compliance of imports
(§ 123.12(a)(2)). FDA estimates the
burden for preparing the new
procedures to be 4 hours per importer
for a total burden of 164 hours.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–14817 Filed 6–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; National Institute
of Diabetes and Digestive and Kidney
Diseases Information Clearinghouses
Customer Satisfaction Survey
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to
provide opportunity for public comment
on proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH),
is giving public notice that the agency
proposes to request reinstatement of an
information collection activity for
which approval expired on February 28,
2010.
Proposed Collection
Title: NIDDK Information
Clearinghouses Customer Satisfaction
Survey. Type of Information Requested:
Reinstatement, with change, of a
previously approved collection for
which approval has expired. The OMB
control number 0925–0480 expired on
February 28, 2010. Need and Use of
Information Collection: NIDDK is
conducting a survey to assess the
efficiency and effectiveness of services
provided by NIDDK’s three
clearinghouses: The National Diabetes
Information Clearinghouse (NDIC); the
National Digestive Diseases Information
Clearinghouse (NDDIC); and the
National Kidney and Urologic Diseases
Information Clearinghouse (NKUDIC).
The survey responds to Executive Order
12821, ‘‘Setting Customer Service
Standards,’’ which requires agencies and
departments to identify and survey their
‘‘customers to determine the kind and
quality of service they want and their
level of satisfaction with existing
services.’’ Frequency of Response: On
occasion. Affected Public: Individuals or
households; business and for profit
organizations; not-for-profit agencies.
Type of Respondents: Physicians, health
care professionals, patients, family and
friends of patients.
The annual reporting burden is as
follows: Estimated number of
respondents: 7,079; estimated number of
responses per respondent: 1; estimated
average burden hours per response:
0.025; and estimated total annual
burden hours requested: 177. The
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Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
annualized cost to respondents is
estimated at $3,793.00. There are no
capital costs to report. There are no
operating or maintenance costs to
report.
Direct Comments to OMB
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the:
Office of Management and Budget,
Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
reports and instrument, contact Kathy
Kranzfelder, Director, NIDDK Office of
Communications and Public Liaison,
Building 31, Room 9A06, MSC2560,
Bethesda, MD 20852 or e-mail your
request, including your address to:
KranzfelderK@mail.nih.gov. To request
more information on the proposed
project or to obtain a copy of the data
collection reports and instrument,
contact Kathy Kranzfelder, Director,
NIDDK Office of Communications and
Public Liaison, Building 31, Room
9A06, MSC2560, Bethesda, MD 20852.
You may also submit comment and data
by electronic mail (e-mail) at
KranzfelderK@mail.nih.gov.
Dated: June 14, 2010.
Lynell Nelson,
NIDDK Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–14793 Filed 6–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–E–0268 and FDA–
2008–E–0267]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BYSTOLIC; U.S. Patent
Nos. 5,759,580 and 6,545,040
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BYSTOLIC and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
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Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. 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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002 301–796–3602.
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
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 drug 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 BYSTOLIC
(nebivolol hydrochloride). BYSTOLIC is
indicated for the treatment of
hypertension. Subsequent to this
approval, the Patent and Trademark
Office received two patent term
restoration applications for BYSTOLIC
(U.S. Patent Nos. 5,759,580 and
6,545,040) from Forest Laboratories,
PO 00000
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34749
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
June 10, 2008, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of BYSTOLIC represented the
first permitted commercial marketing or
use of the product. 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
BYSTOLIC is 6,790 days. Of this time,
5,463 days occurred during the testing
phase and 1,327 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
subsection 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (U.S.C.
355 (i)) involving this drug product
became effective: May 17, 1989. The
applicant claims July 6, 2000, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND originally became effective on May
17, 1989, which was 30 days after FDA
receipt of the original IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the Federal Food, Drug, and
Cosmetic Act: April 30, 2004. The
applicant claims April 29, 2004, as the
date the new drug application (NDA) for
BYSTOLIC (NDA 21–742) was initially
submitted. However, FDA records
indicate that NDA 21–742 was
submitted on April 30, 2004.
3. The date the application was
approved: December 17, 2007. FDA has
verified the applicant’s claim that NDA
21–742 was approved on December 17,
2007. 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 applications for patent extension,
this applicant seeks 1,828 days of patent
term extension for U.S. Patent No.
5,759,580 and 619 days of patent term
extension for U.S. Patent No. 6,545,040.
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 August 17, 2010.
Furthermore, any interested person may
petition FDA for a determination
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]]>Agencies
[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34748-34749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; National Institute of
Diabetes and Digestive and Kidney Diseases Information Clearinghouses
Customer Satisfaction Survey
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to provide opportunity for public
comment on proposed data collection projects, the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the National
Institutes of Health (NIH), is giving public notice that the agency
proposes to request reinstatement of an information collection activity
for which approval expired on February 28, 2010.
Proposed Collection
Title: NIDDK Information Clearinghouses Customer Satisfaction
Survey. Type of Information Requested: Reinstatement, with change, of a
previously approved collection for which approval has expired. The OMB
control number 0925-0480 expired on February 28, 2010. Need and Use of
Information Collection: NIDDK is conducting a survey to assess the
efficiency and effectiveness of services provided by NIDDK's three
clearinghouses: The National Diabetes Information Clearinghouse (NDIC);
the National Digestive Diseases Information Clearinghouse (NDDIC); and
the National Kidney and Urologic Diseases Information Clearinghouse
(NKUDIC). The survey responds to Executive Order 12821, ``Setting
Customer Service Standards,'' which requires agencies and departments
to identify and survey their ``customers to determine the kind and
quality of service they want and their level of satisfaction with
existing services.'' Frequency of Response: On occasion. Affected
Public: Individuals or households; business and for profit
organizations; not-for-profit agencies. Type of Respondents:
Physicians, health care professionals, patients, family and friends of
patients.
The annual reporting burden is as follows: Estimated number of
respondents: 7,079; estimated number of responses per respondent: 1;
estimated average burden hours per response: 0.025; and estimated total
annual burden hours requested: 177. The
[[Page 34749]]
annualized cost to respondents is estimated at $3,793.00. There are no
capital costs to report. There are no operating or maintenance costs to
report.
Direct Comments to OMB
Written comments and/or suggestions regarding the item(s) contained
in this notice, especially regarding the estimated public burden and
associated response time, should be directed to the: Office of
Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk
Officer for NIH. To request more information on the proposed project or
to obtain a copy of the data collection reports and instrument, contact
Kathy Kranzfelder, Director, NIDDK Office of Communications and Public
Liaison, Building 31, Room 9A06, MSC2560, Bethesda, MD 20852 or e-mail
your request, including your address to: KranzfelderK@mail.nih.gov. To
request more information on the proposed project or to obtain a copy of
the data collection reports and instrument, contact Kathy Kranzfelder,
Director, NIDDK Office of Communications and Public Liaison, Building
31, Room 9A06, MSC2560, Bethesda, MD 20852. You may also submit comment
and data by electronic mail (e-mail) at KranzfelderK@mail.nih.gov.
Dated: June 14, 2010.
Lynell Nelson,
NIDDK Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-14793 Filed 6-17-10; 8:45 am]
BILLING CODE 4140-01-P
