Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 30626-30627 [2014-12324]
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emcdonald on DSK67QTVN1PROD with NOTICES
30626
Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological 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 biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product ADCETRIS
(brentuximab vedotin). ADCETRIS as
approved under BLA 125388 is
indicated for treatment of patients with
Hodgkin lymphoma after failure of
autologous stem cell transplant (ASCT)
or after failure of at least two prior
multiagent chemotherapy regimens in
patients who are not ASCT candidates.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
ADCETRIS (U.S. Patent Nos. 7,090,843
and 7,829,531) from Seattle Genetics,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
February 4, 2013, FDA advised the
Patent and Trademark Office that this
human biological product had
undergone a regulatory review period
and that the approval of ADCETRIS
under BLA 125388 and BLA 125399
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
ADCETRIS is 1,851 days. Of this time,
1,678 days occurred during the testing
phase of the regulatory review period,
while 173 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 (21 U.S.C. 355(i))
became effective: July 27, 2006. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 27, 2006. This is the same
investigational new drug application
VerDate Mar<15>2010
16:58 May 27, 2014
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(IND) and the same date FDA
determined was the beginning of the
regulatory review period for ADCETRIS
approved under BLA 125399. The
regulatory review period for ADCETRIS
approved under BLA 125399 is
publishing elsewhere in this issue of the
Federal Register.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): February 28, 2011. FDA has
verified the applicant’s claim that the
BLA for ADCETRIS (BLA 125388) was
initially submitted on February 28,
2011.
3. The date the application was
approved: August 19, 2011. FDA has
verified the applicant’s claim that BLA
125388 was approved on August 19,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the 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 1,002 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) either
electronic or written comments and ask
for a redetermination by July 28, 2014.
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
November 24, 2014. 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 or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
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Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12277 Filed 5–27–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 27, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
National Health Service Corps
Ambassador Portal.
OMB No. 0915–xxxx—New.
Abstract: The National Health Service
Corps (NHSC), administered by the
Health Resources and Services
Administration, is committed to
improving the health of the nation’s
underserved by uniting communities in
need with caring health professionals
and by supporting communities’ efforts
to build better systems of care. The
NHSC programs provide scholarships
and repay educational loans for primary
care physicians, dentists, nurse
practitioners, physician assistants,
behavioral health providers, and other
SUMMARY:
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
primary care providers who agree to
practice in areas of the country that
need them most.
The NHSC invites individuals who
are affiliated with academic, clinical,
trade, and other public health related
organizations to apply to be volunteers
within the NHSC Ambassador Program.
NHSC Ambassadors are dedicated
volunteers who help educate and inform
prospective NHSC members.
Ambassadors give their time and talents
to spread the word about the
opportunities available through the
NHSC and serve as additional local
resources for current NHSC members.
NHSC Ambassadors inspire and
motivate students and providers to
provide primary health care in
communities with limited access to
care.
The NHSC Ambassador Portal will
serve as both the application interface
for interested individuals to apply and
become NHSC Ambassadors, as well the
public-facing online searchable database
of Ambassador contact information.
Applicants will create individual
Ambassador profiles that will contain
information such as name, email
address(es), professional/employment
information (including organization
name and address), (or the school which
they attend), phone number(s), which
discipline of students and/or
professionals they interact with, and a
brief reason why they would like to be
an Ambassador. Completed applications
will be forwarded through the portal to
NHSC staff for approval. If approved,
the NHSC Ambassador will have the
opportunity to add a brief professional
biography and social network addresses
to their profile. Assistance in
completing the application will be
provided through prompts via the
online portal and also through the
NHSC Customer Care Center, if
necessary.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to create a
database where interested parties can
search for NHSC Ambassadors (that
meet specific search criteria) to serve as
local resources on the NHSC programs.
The other purpose is that NHSC can
have access to volunteers who are
available to spread important
programmatic information on behalf of
the NHSC.
Likely Respondents: Individuals who
are affiliated with academic, clinical,
trade, and other public health related
organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Ambassador Portal—New Applicants ..................................
Ambassador Portal—Updates to current Ambassador profiles ...................................................................................
200
1
200
.10
20
500
1
500
.10
50
Total ..............................................................................
700
........................
700
........................
70
Dated: May 20, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with the responsibility for considering
and acting upon the petitions.
[FR Doc. 2014–12324 Filed 5–27–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
emcdonald on DSK67QTVN1PROD with NOTICES
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
SUMMARY:
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
FOR FURTHER INFORMATION CONTACT:
Health Resources and Services
Administration
The
Program provides a system of no-fault
compensation for certain individuals
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
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[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30626-30627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than June 27,
2014.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: National Health Service Corps
Ambassador Portal.
OMB No. 0915-xxxx--New.
Abstract: The National Health Service Corps (NHSC), administered by
the Health Resources and Services Administration, is committed to
improving the health of the nation's underserved by uniting communities
in need with caring health professionals and by supporting communities'
efforts to build better systems of care. The NHSC programs provide
scholarships and repay educational loans for primary care physicians,
dentists, nurse practitioners, physician assistants, behavioral health
providers, and other
[[Page 30627]]
primary care providers who agree to practice in areas of the country
that need them most.
The NHSC invites individuals who are affiliated with academic,
clinical, trade, and other public health related organizations to apply
to be volunteers within the NHSC Ambassador Program. NHSC Ambassadors
are dedicated volunteers who help educate and inform prospective NHSC
members. Ambassadors give their time and talents to spread the word
about the opportunities available through the NHSC and serve as
additional local resources for current NHSC members. NHSC Ambassadors
inspire and motivate students and providers to provide primary health
care in communities with limited access to care.
The NHSC Ambassador Portal will serve as both the application
interface for interested individuals to apply and become NHSC
Ambassadors, as well the public-facing online searchable database of
Ambassador contact information. Applicants will create individual
Ambassador profiles that will contain information such as name, email
address(es), professional/employment information (including
organization name and address), (or the school which they attend),
phone number(s), which discipline of students and/or professionals they
interact with, and a brief reason why they would like to be an
Ambassador. Completed applications will be forwarded through the portal
to NHSC staff for approval. If approved, the NHSC Ambassador will have
the opportunity to add a brief professional biography and social
network addresses to their profile. Assistance in completing the
application will be provided through prompts via the online portal and
also through the NHSC Customer Care Center, if necessary.
Need and Proposed Use of the Information: The need and purpose of
this information collection is to create a database where interested
parties can search for NHSC Ambassadors (that meet specific search
criteria) to serve as local resources on the NHSC programs. The other
purpose is that NHSC can have access to volunteers who are available to
spread important programmatic information on behalf of the NHSC.
Likely Respondents: Individuals who are affiliated with academic,
clinical, trade, and other public health related organizations.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Ambassador Portal--New 200 1 200 .10 20
Applicants.....................
Ambassador Portal--Updates to 500 1 500 .10 50
current Ambassador profiles....
-------------------------------------------------------------------------------
Total....................... 700 .............. 700 .............. 70
----------------------------------------------------------------------------------------------------------------
Dated: May 20, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-12324 Filed 5-27-14; 8:45 am]
BILLING CODE 4165-15-P
