Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57549-57550 [E6-15960]
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Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Notices
Rockville Pike, Rockville, MD 20852,
301–827–0373, e-mail:
robert.yetter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
During the past decade, FDA has been
working to expand its ability to receive
and review marketing applications
electronically. In addition, the agency
has been working through the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH) to
harmonize the formats being used for
marketing applications.
Beginning in 1999, FDA issued two
guidances and one draft guidance for
industry that made recommendations to
applicants wishing to submit
applications to FDA in electronic
format: (1) ‘‘Providing Regulatory
Submissions in Electronic Format—
NDAs’’ (e-NDA guidance) (64 FR 4432,
January 28, 1999), (2) ‘‘Providing
Regulatory Submissions in Electronic
Format—ANDAs’’ (e-ANDA guidance)
(67 FR 43331, June 27, 2002), and (3)
‘‘Providing Regulatory Submissions in
Electronic Format—Annual Reports for
New Drug Applications and
Abbreviated New Drug Applications’’
(draft) (68 FR 51788, August 28, 2003).
In general, these guidances
recommended submitting documents as
portable document files (PDF),
electronic data/case report tabulations
as SAS transport files, and the NDA
table of contents in PDF format. In the
meantime, however, the FDA adopted
the ICH Common Technical Document
(CTD) headings and subheadings for
marketing applications. ICH then issued
specifications for the electronic version
of the CTD (e-CTD).
In October 2005, FDA issued the
guidance ‘‘Providing Regulatory
Submissions in Electronic Format—
Human Pharmaceutical Product
Applications and Related Submissions
Using the e-CTD Specifications’’ (the eCTD guidance) (70 FR 60842; October
19, 2005). This guidance differs from the
e-NDA and e-ANDA guidances in one
significant aspect: The application table
of contents is no longer submitted as a
PDF file, but is submitted as an XML
(extensible markup language) file. This
XML file has numerous advantages over
the older PDF format, most significant of
which is the ability to update the
application table of contents
automatically as new amendments are
received. With the e-CTD format,
sponsors and reviewers now have access
to a real-time, up-to-date, cumulative
table of contents that provides easy and
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immediate access to all files included in
an application, regardless of when they
were included, or in what submission
they are located. This has never
previously been possible. Another
advantage is that the table of contents
can be displayed in various ways,
allowing discipline-specific views of an
application, further promoting review
efficiency. This is especially important
for agency review staff. For example,
although all portions of an application
are always available to all reviewers, a
chemist would be interested in different
portions of the application than a
clinical reviewer. The XML table of
contents permits reviewers to view the
application in a manner that makes the
most sense to support their particular
review activity.
Despite the release of the e-CTD
guidance describing the use of the XML
format, FDA has continued to make all
three guidances available with their
differing recommendations. As a result,
applicants have had three choices when
submitting a marketing application
electronically: (1) Use the e-NDA/eANDA format, (2) use the e-CTD format,
or (3) use what we call a ‘‘hybrid’’
submission (the older e-NDA format
with the table of contents organized
using the newer CTD headings). In
addition, FDA still receives submissions
that are a combination of paper and
electronic formats. Of course, this
would not be appropriate for sponsors
who are using the e-CTD format, as
doing this would negate the intent of
having all portions of the application
readily available for review via the XML
table of contents. A result of having this
variety of choices is confusion and
frustration for industry, who are not
receiving consistent recommendations
about how to submit marketing
applications. It is also confusing and
frustrating for our review staff. In
addition, our willingness to receive
applications in a variety of different
forms has forced the agency to maintain
expensive and duplicative processes
and systems for receiving and archiving
these various application types.
II. Withdrawal of Guidances
The e-CTD format is preferred by FDA
because it is more efficient than the
other choices and consistent with FDA’s
technical capabilities. The e-CTD format
is also the preferred ICH format. As a
result, the agency is withdrawing the
earlier guidances. In addition, we will
remove references to these guidances
from the electronic submissions docket
on December 31, 2007. Further
information on providing regulatory
submissions in electronic format can be
found on Docket No. 1992S–0251
PO 00000
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57549
(formerly Docket No. 92S–0251) (https://
www.fda.gov/ohrms/dockets/dockets/
92s0251/92s0251.htm). We are
recommending that sponsors wishing to
submit applications electronically use
the most efficient and internationally
agreed to formats recommended in our
most recent guidance.
Although the Center for Biologics
Evaluation and Research (CBER)
supports the use of the e-CTD format
and encourages its sponsors to use this
format when creating its submissions,
CBER also recognizes that in certain
situations a sponsor may not be capable
of providing submissions in that format
at this time. Therefore, CBER
recommends that sponsors who cannot
use the e-CTD format consult guidance
for industry ‘‘Providing Regulatory
Submissions to the Center for Biologics
Evaluation and Research (CBER) in
Electronic Format—Biologics Marketing
Applications [Biologics License
Application (BLA), Product License
Application (PLA) / Establishment
License Application (ELA) and New
Drug Application (NDA)] (11/12/1999)
(available online at https://www.fda.gov/
cber/esub/esubguid.htm).
Dated: September 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–15966 Filed 9–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The Health Education
Assistance Loan (HEAL) Program:
Forms (OMB No. 0915–0043 Extension)
The Health Education Assistance
Loan (HEAL) program continues to
administer and monitor outstanding
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57550
Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Notices
loans which were provided to eligible
students to pay for educational costs in
a number of health professions. HEAL
forms collect information that is
required for responsible program
management. The HEAL Repayment
Schedule, Fixed and Variable, provides
the borrower with the cost of a HEAL
loan, the number and amount of
payments, and the Truth-in-Lending
disclosures. The Lender’s Report on
HEAL Student Loans Outstanding (Call
Report), provides information on the
status of loans outstanding by the
number of borrowers and total number
of loans whose loan payments are in
various stages of the loan cycle, such as
student education and repayment, and
Responses
per
respondent
Number of
respondents
Form and number
the corresponding dollar amounts.
These forms are needed to provide
borrowers with information on the cost
of their loan(s) and to determine which
lenders may have excessive
delinquencies and defaulted loans.
The estimate of burden for the forms
is as follows:
Total responses
Hours per
responses
Total burden
hours
Disclosure:
Repayment Schedule HRSA 502–1,2 ..........................
Reporting:
Call Report HRSA 512 .................................................
8
666
5,328
0.50
2,664
20
4
80
0.75
60
Total Reporting and Disclosure .............................
28
........................
5,408
........................
2,724
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: September 22, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–15960 Filed 9–28–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Web-Based Semi
Annual Report (SAR) (OMB No. 0915–
0262)—Extension
reporting requirements for the primary
care grantees funded by BPHC using the
Web-based Semi Annual Report (SAR).
The SAR includes reporting
requirements for grantees of the
following primary care programs: State
Primary Care Associations and State
Primary Care Offices. Authorizing
legislation is found in Section 330(m) of
the Public Health Service Act, as
amended.
BPHC collects data on its programs to
ensure compliance with legislative
mandates and to monitor and report on
program accomplishments. To meet
these objectives, BPHC requires a core
set of information collected semiannually that is appropriate for
monitoring and evaluating performance
and reporting on annual trends. The
SAR has been a valuable instrument for
collecting this information from
grantees. The SAR provides data on
services, characteristics of populations,
leveraged funds, and services that fall
within the scope of the grant.
Estimates of annualized burden are as
follows:
The HRSA’s Bureau of Primary Health
Care (BPHC) collects the annual
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
SAR ......................................................................................
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]]>Agencies
[Federal Register Volume 71, Number 189 (Friday, September 29, 2006)]
[Notices]
[Pages 57549-57550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15960]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, call the
HRSA Reports Clearance Office on (301) 443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: The Health Education Assistance Loan (HEAL) Program:
Forms (OMB No. 0915-0043 Extension)
The Health Education Assistance Loan (HEAL) program continues to
administer and monitor outstanding
[[Page 57550]]
loans which were provided to eligible students to pay for educational
costs in a number of health professions. HEAL forms collect information
that is required for responsible program management. The HEAL Repayment
Schedule, Fixed and Variable, provides the borrower with the cost of a
HEAL loan, the number and amount of payments, and the Truth-in-Lending
disclosures. The Lender's Report on HEAL Student Loans Outstanding
(Call Report), provides information on the status of loans outstanding
by the number of borrowers and total number of loans whose loan
payments are in various stages of the loan cycle, such as student
education and repayment, and the corresponding dollar amounts. These
forms are needed to provide borrowers with information on the cost of
their loan(s) and to determine which lenders may have excessive
delinquencies and defaulted loans.
The estimate of burden for the forms is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form and number respondents respondent responses responses hours
----------------------------------------------------------------------------------------------------------------
Disclosure:
Repayment Schedule HRSA 502- 8 666 5,328 0.50 2,664
1,2........................
Reporting:
Call Report HRSA 512........ 20 4 80 0.75 60
-------------------------------------------------------------------------------
Total Reporting and 28 .............. 5,408 .............. 2,724
Disclosure.............
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503.
Dated: September 22, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-15960 Filed 9-28-06; 8:45 am]
BILLING CODE 4165-15-P
