Proposed Collection; Comment Request; GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers, 77880-77881 [2010-31377]
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77880
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
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 SAMSCA
(tolvaptan). SAMSCA is indicated for
the treatment of clinically significant
hypervolemic and euvolemic
hyponatremia, including patients with
heart failure, cirrhosis, and Syndrome of
Inappropriate Antidiuretic Hormone.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
SAMSCA (U.S. Patent Nos. 5,258,510
and 5,753,677) from Otsuka
Pharmaceutical Co., Ltd., and the Patent
and Trademark Office requested FDA’s
assistance in determining these patents’
eligibility for patent term restoration. In
a letter dated March 3, 2010, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of SAMSCA
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
SAMSCA is 4,722 days. Of this time,
4,147 days occurred during the testing
phase of the regulatory review period,
while 575 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 FD&C Act) (21
U.S.C. 355(i)) became effective: June 16,
1996. The applicant claims October 23,
1997, as the date the investigational new
drug application (IND) became effective.
However, according to FDA records, this
IND was not the first IND received for
this active ingredient. In general, FDA
has used the first IND of the active
ingredient of the drug product as the
beginning of the testing phase, if
information derived from this first IND
was or could have been relied on or was
relevant for approval to market the drug
product. FDA records indicate that the
effective date of the first IND for
tolvaptan was June 16, 1996, which was
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17:09 Dec 13, 2010
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30 days after FDA receipt of this first
IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 23,
2007. FDA has verified the applicant’s
claim that the new drug application
(NDA) for SAMSCA (NDA 22–275) was
submitted on October 23, 2007.
3. The date the application was
approved: May 19, 2009. FDA has
verified the applicant’s claim that NDA
22–275 was approved on May 19, 2009.
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 1,826 days or 1,827
days respectively 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) either
electronic or written comments and ask
for a redetermination by February 14,
2011. 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 June 13, 2011. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–31298 Filed 12–13–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; GuLF Worker Study: Gulf
Long-Term Follow-Up Study for Oil
Spill Clean-Up Workers and Volunteers
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on 7 October 2010
on pages 62132–3 and allowed 60-days
for public comment. One public
comment was received and addressed
regarding the appropriateness and
sources for funding the survey. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
5 CFR 1320.5: Reporting and
Recordkeeping Requirements: Final
Rule: Respondents to this collection of
information are not required to respond
unless the data collection instruments
display a currently valid OMB control
number.
SUMMARY:
Proposed Collection
Title: GuLF Worker Study: Gulf LongTerm Follow-Up Study for Oil Spill
Clean-Up Workers and Volunteers. Type
of Information Collection Request: New.
Need and Use of Information Collection:
The purpose of the GuLF Study is to
investigate potential short- and longterm health effects associated with oil
spill clean-up activities and exposures
surrounding the Deepwater Horizon
disaster; and to create a resource for
additional collaborative research on
focused hypotheses or subgroups. Over
55,000 persons participating in oil-spill
clean-up activities have been exposed to
a range of known and suspected toxins
in crude oil, burning oil, and
dispersants, to excessive heat, and
possibly to stress due to widespread
economic and lifestyle disruption.
Exposures range from negligible to
potentially significant, however,
potential long-term human health
E:\FR\FM\14DEN1.SGM
14DEN1
77881
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
consequences are largely unknown due
to insufficient research in this area.
Participants will be recruited from
across job/exposure groups of primarily
English, Spanish, or Vietnamese
speaking adults (accommodations for
other languages developed as
appropriate) who performed oil-spill
clean-up-related work (‘‘exposed’’) and
similar persons who did not
(‘‘unexposed’’ controls), and followed in
either an Active Follow-up Cohort
(N∼27,000) or a Passive Follow-up
Cohort (N∼28,000). Exposures will be
estimated using detailed job-exposure
matrices developed from data from
monitoring performed by different
agencies and organizations during the
crisis, information obtained by
interview, and the available scientific
literature. We will investigate acute
health effects among all cohort members
via self-report from the enrollment
interview, and via clinical measures and
biological samples from Active Followup Cohort members only. All cohort
members will be followed for
development of a range of health
outcomes through record linkage (e.g.,
cancer, mortality) and possibly through
linkage with routinely collected health
surveillance data (collected by health
departments and the CDC) or with
electronic medical records. Recruitment
of subjects should begin in late 2010,
with telephone interviews and the
baseline home visits conducted within
18 months.
Estimated
number of
respondents
Estimated
responses per
respondent
Burden hours
per response
Total burden
hours per
respondent
Estimated
total burden
hours
Ineligible respondents ..........................................................
Enrollment interview (All) .....................................................
Home Visit (Active) ..............................................................
Annual Contact Info Update (Passive) ................................
Annual Contact Info Update (Active) ...................................
Biennial interview (Active) ....................................................
Passive Cohort Total responses & hrs .........................
Active Cohort Total responses & hrs ...........................
TOTAL responses & avg hrs per response ..........
Average per year ............................................
srobinson on DSKHWCL6B1PROD with NOTICES
Activity (3-yrs)
25,000
55,000
27,000
28,000
27,000
27,000
........................
........................
........................
........................
1
1
1
3
2
1
4
5
9
........................
0.25
0.50
2.75
0.25
0.25
0.50
........................
........................
........................
........................
0.25
0.50
2.75
0.75
0.50
0.50
1.25
4.25
0.58
........................
6,250
27,500
74,250
21,000
13,500
13,500
........................
........................
156,000
52,000
Frequency of Response: Participation
will include one enrollment telephone
interview (0.5 hr); collection of
biological and environmental samples,
basic clinical measurements, and GPS
coordinates (2.75 hr) from the Active
Follow-up Cohort only; annual contact
information update (0.25; Active and
Passive) or biennial follow-up telephone
or Web interviews (0.5 hr; Active only)
for 10 years or more. We also anticipate
screening 25,000 ineligible respondents.
Affected Public: Individuals or
households. Type of Respondents:
Workers involved in Deepwater Horizon
disaster clean-up, and similar
individuals not involved in clean-up
effort. The annual reporting burden is as
follows: Estimated Number of
Respondents: Active Follow-up Cohort
(N∼27,000) and Passive Follow-up
Cohort (N∼28,000).
Estimated Number of Responses per
Respondent: See table.
Average Burden Hours Per Response:
0.58 hour; and Estimated Total Burden
Hours Requested: 156,000 (over 3 years).
The average annual burden hours
requested is 52,000. The annualized cost
to respondents is estimated at $11.60
(assuming $20 hourly wage × 0.58 hour).
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
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17:09 Dec 13, 2010
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performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
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 project or to obtain
a copy of the data collection plans and
instruments, contact: Dr. Dale P.
Sandler, Chief, Epidemiology Branch,
NIEHS, Rall Building A3–05, PO Box
12233, Research Triangle Park, NC
27709; non-toll-free number 919–541–
4668 or e-mail sandler@niehs.nih.gov.
Include your address.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
PO 00000
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received within 30 days of the date of
this publication.
Dated: December 9, 2010.
W. Christopher Long,
NIEHS, Acting Associate Director for
Management, National Institutes of Health.
[FR Doc. 2010–31377 Filed 12–13–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Recruitment and
Screening for the Insight Into
Determination of Exceptional Aging
and Longevity (IDEAL) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Aging (NIA), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on September 17,
2010, page 57038 and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30-days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
SUMMARY:
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77880-77881]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; GuLF Worker Study: Gulf
Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Environmental Health
Sciences (NIEHS), the National Institutes of Health (NIH) has submitted
to the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below. This proposed
information collection was previously published in the Federal Register
on 7 October 2010 on pages 62132-3 and allowed 60-days for public
comment. One public comment was received and addressed regarding the
appropriateness and sources for funding the survey. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Institutes of Health may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule:
Respondents to this collection of information are not required to
respond unless the data collection instruments display a currently
valid OMB control number.
Proposed Collection
Title: GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil
Spill Clean-Up Workers and Volunteers. Type of Information Collection
Request: New. Need and Use of Information Collection: The purpose of
the GuLF Study is to investigate potential short- and long-term health
effects associated with oil spill clean-up activities and exposures
surrounding the Deepwater Horizon disaster; and to create a resource
for additional collaborative research on focused hypotheses or
subgroups. Over 55,000 persons participating in oil-spill clean-up
activities have been exposed to a range of known and suspected toxins
in crude oil, burning oil, and dispersants, to excessive heat, and
possibly to stress due to widespread economic and lifestyle disruption.
Exposures range from negligible to potentially significant, however,
potential long-term human health
[[Page 77881]]
consequences are largely unknown due to insufficient research in this
area. Participants will be recruited from across job/exposure groups of
primarily English, Spanish, or Vietnamese speaking adults
(accommodations for other languages developed as appropriate) who
performed oil-spill clean-up-related work (``exposed'') and similar
persons who did not (``unexposed'' controls), and followed in either an
Active Follow-up Cohort (N~27,000) or a Passive Follow-up Cohort
(N~28,000). Exposures will be estimated using detailed job-exposure
matrices developed from data from monitoring performed by different
agencies and organizations during the crisis, information obtained by
interview, and the available scientific literature. We will investigate
acute health effects among all cohort members via self-report from the
enrollment interview, and via clinical measures and biological samples
from Active Follow-up Cohort members only. All cohort members will be
followed for development of a range of health outcomes through record
linkage (e.g., cancer, mortality) and possibly through linkage with
routinely collected health surveillance data (collected by health
departments and the CDC) or with electronic medical records.
Recruitment of subjects should begin in late 2010, with telephone
interviews and the baseline home visits conducted within 18 months.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated Total burden Estimated
Activity (3-yrs) number of responses per Burden hours hours per total burden
respondents respondent per response respondent hours
----------------------------------------------------------------------------------------------------------------
Ineligible respondents.......... 25,000 1 0.25 0.25 6,250
Enrollment interview (All)...... 55,000 1 0.50 0.50 27,500
Home Visit (Active)............. 27,000 1 2.75 2.75 74,250
Annual Contact Info Update 28,000 3 0.25 0.75 21,000
(Passive)......................
Annual Contact Info Update 27,000 2 0.25 0.50 13,500
(Active).......................
Biennial interview (Active)..... 27,000 1 0.50 0.50 13,500
Passive Cohort Total .............. 4 .............. 1.25 ..............
responses & hrs............
Active Cohort Total .............. 5 .............. 4.25 ..............
responses & hrs............
TOTAL responses & avg .............. 9 .............. 0.58 156,000
hrs per response.......
Average per year.... .............. .............. .............. .............. 52,000
----------------------------------------------------------------------------------------------------------------
Frequency of Response: Participation will include one enrollment
telephone interview (0.5 hr); collection of biological and
environmental samples, basic clinical measurements, and GPS coordinates
(2.75 hr) from the Active Follow-up Cohort only; annual contact
information update (0.25; Active and Passive) or biennial follow-up
telephone or Web interviews (0.5 hr; Active only) for 10 years or more.
We also anticipate screening 25,000 ineligible respondents. Affected
Public: Individuals or households. Type of Respondents: Workers
involved in Deepwater Horizon disaster clean-up, and similar
individuals not involved in clean-up effort. The annual reporting
burden is as follows: Estimated Number of Respondents: Active Follow-up
Cohort (N~27,000) and Passive Follow-up Cohort (N~28,000).
Estimated Number of Responses per Respondent: See table.
Average Burden Hours Per Response: 0.58 hour; and Estimated Total
Burden Hours Requested: 156,000 (over 3 years). The average annual
burden hours requested is 52,000. The annualized cost to respondents is
estimated at $11.60 (assuming $20 hourly wage x 0.58 hour). There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency'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 those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
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
project or to obtain a copy of the data collection plans and
instruments, contact: Dr. Dale P. Sandler, Chief, Epidemiology Branch,
NIEHS, Rall Building A3-05, PO Box 12233, Research Triangle Park, NC
27709; non-toll-free number 919-541-4668 or e-mail
sandler@niehs.nih.gov. Include your address.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: December 9, 2010.
W. Christopher Long,
NIEHS, Acting Associate Director for Management, National Institutes of
Health.
[FR Doc. 2010-31377 Filed 12-13-10; 8:45 am]
BILLING CODE 4140-01-P
