Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 50297-50298 [2015-20473]
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Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
50297
TABLE 2—FEES FOR ORIGINAL AND SUBSEQUENT EXPORT CERTIFICATES
Type of certificate
Fee (dollars)
Original certificates (may be multiple in number) 1 .............................................................................................................
All subsequent certificates issued for the same product(s) in response to the same request 1 ........................................
1 As
calculated under formula.
Under its formula for calculating
applicable fees, CDRH has allowed
multiple devices to be included in a
single certificate rather than requiring
that each device have a separate
certificate for which a fee is charged.
While CDRH will continue to allow
multiple devices to be included in a
single certificate, it is revising the
formula by which the number of
original device export certificates (at
$175 per certificate) and subsequent
certificates (at $85 per certificate) will
be calculated. The number of original
and subsequent device export
certificates will be calculated using a
revised formula that sets the maximum
pages per certificate to 25 pages (the
certificate page and a maximum of 24
pages for any attachments). Previously,
the maximum number of pages was 50.
If the request is more than 25 pages,
then the total number of pages created
by the request is divided by 25 and that
number will be the number of original
certificates that will be charged at $175
and the remaining number of
subsequent certificates will be charged
at $85 each. For example, if you request
15 certificates and each certificate has
12 attachment pages plus the certificate
page that means each certificate is 13
pages, and your request will generate
195 pages in all. This number of pages
is divided by 25 and that equals 7.8,
which is rounded to 8. Therefore, you
will be charged for 8 original certificates
at $175 each and 7 subsequent
certificates at $85 each. Please note the
maximum number of attachment pages
is 24 pages. If you have more than 24
pages you will need to split the request
into two or more requests.
tkelley on DSK3SPTVN1PROD with NOTICES
175
85
III. Request for Comments
Although the EREA does not require
FDA to solicit comments on the
assessment and collection of fees for
export certificates, FDA is inviting
comments from interested persons in
order to have the benefit of additional
views.
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
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19:14 Aug 18, 2015
Jkt 235001
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. The Paperwork Reduction Act of
1995
This notice refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in sections 801(e) and
802 of the FD&C Act have been
approved under OMB control number
0910–0498.
Dated: August 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20429 Filed 8–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank (NLM)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, 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 June 10, 2015,
page 32968 and allowed 60-days for
public comment. One public comment
was received. The purpose of this notice
is to allow an additional 30 days for
public comment. The National Library
of Medicine (NLM), 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.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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: NIH Desk Officer.
Comment 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.
For Further Information Contact: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: David Sharlip, Office of
Administrative and Management
Analysis Services, National Library of
Medicine, Building 38A, Room B2N12,
8600 Rockville Pike, Bethesda, MD
20894, or call non-toll-free number (301)
402–9680, or Email your request,
including your address to: sharlipd@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank (NLM),
0925–0586, Expiration Date 08/31/2015,
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies,
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
E:\FR\FM\19AUN1.SGM
19AUN1
50298
Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
While many clinical studies are
registered and submit results
information voluntarily, FDAAA
requires the registration of certain
applicable clinical trials of drugs and
devices and the submission of results
information for completed applicable
clinical trials of drugs and devices that
are approved, licensed, or cleared by the
Food and Drug Administration.
Beginning in 2009, results information
was required to include information
NIH is continuing to review submitted
public comments as it prepares the final
rule. The NIH will make any
corresponding changes to the
ClinicalTrials.gov information
collection via separate procedure.
OMB approval is requested for 3
years. There are no costs to respondents
other than there their time. The total
estimated annualized burden hours are
682,535.
about serious and frequent adverse
events.
This extension request does not
include any changes to the information
submission requirements for
ClinicalTrials.gov that were proposed in
the Notice of Proposed Rulemaking on
Clinical Trial Registration and Results
Submission that was issued on
November 21, 2014 and for which the
public comment period closed on March
23, 2015 (79 FR 225, Nov. 21, 2014). The
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
PRS Account ...................................................................................................
Initial Registration ............................................................................................
Updates ............................................................................................................
Initial Results ...................................................................................................
Updates ............................................................................................................
Certification to Delay Results ..........................................................................
Extension Request ...........................................................................................
Dated: August 13, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015–20473 Filed 8–18–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; National Toxicology Program
(NTP) Level of Concern Categories
Study (NIEHS)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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
VerDate Sep<11>2014
19:14 Aug 18, 2015
Jkt 235001
5,700
23,000
23,000
3,700
3,700
700
30
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.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. Kristina Thayer,
Director of the Office of Health
Assessment and Translation, Division of
National Toxicology Program, NIEHS,
P.O. Box 12233, Mail Drop K2–04,
Research Triangle Park, NC 27709, or
call non-toll-free number (919) 541–
5021, or Email your request, including
your address to: thayer@niehs.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
8
1
2
1
1
Average time
per response
(in hours)
15/60
7
2
25
8
30/60
2
Total annual
hour burden
1,425
161,000
368,000
92,500
59,200
350
60
Proposed Collection: National
Toxicology Program Level of Concern
Categories, 0925–NEW, National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Toxicology
Program (NTP) has used a 5-point level
of concern (LoC) framework to
communicate NTP’s assessment of the
degree of concern regarding the
potential human health effects of
selected substances given what is
known about their toxicity, level of
human exposure, and pharmacokinetics.
As part of its systematic review
methodologies, the NTP is updating its
LoC framework to enhance transparency
in what the LoC categories mean,
describing the factors considered in
reaching conclusions and identifying
strategies for improving their use as a
risk communication tool. This study
will use expert solicitation from five
NTP stakeholder sectors (academia,
industry, non-government
organizations, and federal and state
agencies) to aid in determining the
optimal number of LoC categories for an
updated LoC framework.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
300.
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50297-50298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Information
Program on Clinical Trials: Maintaining a Registry and Results Databank
(NLM)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, 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 June 10, 2015, page 32968 and allowed 60-days
for public comment. One public comment was received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Library of Medicine (NLM), 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.
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: NIH Desk Officer.
Comment 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.
For Further Information Contact: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: David Sharlip, Office of Administrative and
Management Analysis Services, National Library of Medicine, Building
38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-
toll-free number (301) 402-9680, or Email your request, including your
address to: sharlipd@mail.nih.gov. Formal requests for additional plans
and instruments must be requested in writing.
Proposed Collection: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank (NLM), 0925-0586,
Expiration Date 08/31/2015, EXTENSION, National Library of Medicine
(NLM), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Institutes of
Health operates ClinicalTrials.gov, which was established as a clinical
trial registry under section 113 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include
a results data bank by Title VIII of the Food and Drug Administration
Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects
registration and results information for clinical trials and other
types of clinical studies (e.g., observational studies and patient
registries) with the objectives of enhancing patient enrollment and
providing a mechanism for tracking subsequent progress of clinical
studies, to the benefit of public health. It is widely used by
patients, physicians, and medical researchers; in particular those
involved in clinical research.
[[Page 50298]]
While many clinical studies are registered and submit results
information voluntarily, FDAAA requires the registration of certain
applicable clinical trials of drugs and devices and the submission of
results information for completed applicable clinical trials of drugs
and devices that are approved, licensed, or cleared by the Food and
Drug Administration. Beginning in 2009, results information was
required to include information about serious and frequent adverse
events.
This extension request does not include any changes to the
information submission requirements for ClinicalTrials.gov that were
proposed in the Notice of Proposed Rulemaking on Clinical Trial
Registration and Results Submission that was issued on November 21,
2014 and for which the public comment period closed on March 23, 2015
(79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted
public comments as it prepares the final rule. The NIH will make any
corresponding changes to the ClinicalTrials.gov information collection
via separate procedure.
OMB approval is requested for 3 years. There are no costs to
respondents other than there their time. The total estimated annualized
burden hours are 682,535.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) hour burden
----------------------------------------------------------------------------------------------------------------
PRS Account..................................... 5,700 1 15/60 1,425
Initial Registration............................ 23,000 1 7 161,000
Updates......................................... 23,000 8 2 368,000
Initial Results................................. 3,700 1 25 92,500
Updates......................................... 3,700 2 8 59,200
Certification to Delay Results.................. 700 1 30/60 350
Extension Request............................... 30 1 2 60
----------------------------------------------------------------------------------------------------------------
Dated: August 13, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015-20473 Filed 8-18-15; 8:45 am]
BILLING CODE 4140-01-P
