Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 20929-20931 [2013-08071]
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Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
workshop will be Webcast. Persons
interested in viewing the Webcast must
register online by 5 p.m. on June 14,
2013. Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and connection access
information after June 19, 2013. An
archived file of the Webcast will be
available approximately 45 days after
the public workshop on the Internet at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
Workshop format: This workshop will
begin with plenary sessions to outline
the three primary areas of focus for the
CDRH HoW Program. In each area,
panels will examine major themes using
data-driven case studies with a focus on
practical strategies relevant to particular
challenges in the medical device arena.
Participants will then rotate through
breakout sessions, collectively building
an action plan for each activity area.
The meeting will conclude with specific
commitments by stakeholder groups to
partner with CDRH and each other in a
collaborative effort to educate, enable,
enlist and explore, with a common goal
of improving the health of women.
Comments: In order to permit the
widest possible opportunity to obtain
public information from interested
persons on the workshop topics, FDA is
opening the docket to gather electronic
or written comments on the three areas
of focus for the HoW workshop
identified in section II. Comments
received will be reviewed by FDA as
part of this effort. The deadline for
submitting comments related to this
public workshop topic is July 31, 2013.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic or written
comments. Submit electronic comments
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. Please identify comments
with the docket number found in
brackets in the heading of this
document. In addition, when
responding to specific topics as outlined
in section II, please identify the topic
you are addressing. 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
VerDate Mar<15>2010
20:02 Apr 05, 2013
Jkt 229001
posted to the docket at https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The mission of the CDRH Health of
Women (HoW) Program:
To improve the health of women by:
• Improving the availability,
consistency, and communication of sexspecific information for the safe and
effective use of medical devices in
women;
• addressing identified gaps and
unmet needs through targeted resources;
and
• fostering the development of
innovative strategies, technology, and
clinical study paradigms.
A key priority in regulatory science
for CDRH is improving the health of
special populations and addressing their
unique health-related issues.1 CDRH
recognizes women as a special
population, and seeks to identify and
address differences in the safety,
effectiveness, and utilization of medical
devices for women. There are unique
issues in the regulation of medical
devices for use by women, which
include:
• Uncertainty about medical device
performance in women due to
inconsistent data analysis and underrepresentation of women in clinical
trials
• Baseline differences in anatomy,
physiology, risk factors, disease signs/
symptoms, and comorbidities that may
be associated with different outcomes of
device use
• Potential differences in health
communication/health seeking behavior
that may impact FDA communication of
medical device benefit-risk information
to this population
• Different considerations regarding
effects of hormones through life stages
(first menstrual period (menarche) to
menopause; hormone replacement
therapy)
• Unique risks and needs related to
medical device research involving
women of childbearing potential
• Unique risks and needs for pregnant
females associated with the use of
medical devices, including risk of birth
defects (teratogenicity) or complications
of pregnancy arising from medical
device components such as drugs,
chemicals, and certain biomaterials
1 Food and Drug Administration, ‘‘Regulatory
Science in FDA’s Center for Devices and
Radiological Health: A Vital Framework for
Protecting and Promoting Public Health,’’ https://
www.fda.gov/downloads/AboutFDA/
CentersOffices/CDRH/CDRHReports/
ucm274162.pdf.
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20929
II. Topics for Discussion in the Docket
and at the Public Workshop
Topics for discussion include:
1. Device-specific clinical study
recruitment and retention strategies;
2. Analysis and communication of
sex-specific findings to providers and
patients; and
3. Priority research road map for the
HoW device ecosystem.
Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08015 Filed 4–5–13; 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
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
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.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
SUMMARY:
Information Collection Request Title:
National Practitioner Data Bank for
Adverse Information on Physicians and
Other Health Care Practitioners—45
CFR Part 60 Regulations and Forms
OMB No. 0915–0126—Revision
Abstract: This is a request for a
revision of OMB approval of the
information collections contained in
regulations found at 45 CFR part 60
governing the National Practitioner Data
Bank (NPDB) and the forms to be used
in registering with, reporting
information to, and requesting
information from the NPDB. Section
6403 of the Patient Protection and
Affordable Care Act of 2010 (Affordable
Care Act) Public Law 111–148 requires
the transfer of all data in the Healthcare
Integrity and Protection Data Bank
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Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
(HIPDB) to the NPDB. Data collection
will not change; however, the merger
will consolidate forms from OMB No.
0915–0239 for HIPDB under OMB No.
0915–0126 for NPDB. Responsibility for
NPDB implementation and operation
resides in the Bureau of Health
Professions, Health Resources and
Services Administration (HRSA),
Department of Health and Human
Services (HHS). Operation of the HIPDB
was delegated by the HHS Office of the
Inspector General to HRSA. This rule
eliminates duplicative data reporting
and access requirements between the
HIPDB [established through the Health
Insurance Portability and
Accountability Act of 1996 (HIPPA)
under Section 1128(b)(5) of the Social
Security Act (42 U.S.C. 1320a–7e)] and
the NPDB [established through the
Health Care Quality Improvement Act of
1986 under Title IV (42 U.S.C. 11101 et
seq.) and expanded by Section 1921 of
the Social Security Act (42 U.S.C.
1396r–2)]. Information previously
collected and disclosed through the
HIPDB will be collected and disclosed
through the NPDB. Section 6403 of the
Affordable Care Act consolidates the
collection and disclosure of information
from both data banks under Title 45 part
60 of the Code of Federal Regulations
(CFR). HHS will subsequently remove
Title 45 part 61, which implemented the
HIPDB.
The intent of NPDB is to improve the
quality of health care by encouraging
hospitals, state licensing boards,
professional societies, and other entities
providing health care services, to
identify and discipline those who
engage in unprofessional behavior; and
to restrict the ability of incompetent
health care practitioners, providers, or
suppliers to move from state to state
without disclosure of previous
damaging or incompetent performance.
It also serves as a fraud and abuse
clearinghouse for the reporting and
disclosing of certain final adverse
actions (excluding settlements in which
no findings of liability have been made)
taken against health care practitioners,
providers, or suppliers by health plans,
federal agencies, and state agencies.
The NPDB acts primarily as a flagging
system; its principal purpose is to
facilitate comprehensive review of
practitioners’ professional credentials
and background. Information is
collected from, and disseminated to,
eligible entities (entities that are entitled
to query and/or report to the NPDB
under the three aforementioned
statutory authorities) on the following:
(1) Medical malpractice payments, (2)
licensure actions taken by Boards of
Medical Examiners, (3) state licensure
and certification actions, (4) federal
licensure and certification actions, (5)
negative actions or findings taken by
peer review organizations or private
accreditation entities, (6) adverse
actions taken against clinical privileges,
(7) federal or state criminal convictions
related to the delivery of a health care
item or service, (8) civil judgments
related to the delivery of a health care
item or service, (9) exclusions from
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Regulation citation
Form name
§ 60.6: Reporting errors,
omissions, revisions or
whether an action is on
appeal.
§ 60.7: Reporting medical
malpractice payments.
§ 60.8: Reporting licensure
actions taken by Boards
of Medical Examiners &
§ 60.9: Reporting licensure and certification actions taken by States.
§ 60.10: Reporting Federal
licensure and certification
actions.
§ 60.11: Reporting negative
actions or findings taken
by peer review organizations or private accreditation entities.
Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal.
Medical Malpractice Payment.
State Licensure ...................
Responses
per
respondent
participation in federal or state health
care programs, and (10) other
adjudicated actions or decisions. It is
intended that NPDB information should
be considered with other relevant
information in evaluating credentials of
health care practitioners, providers, and
suppliers.
The reporting forms and the request
for information forms (query forms) are
accessed, completed, and submitted to
the NPDB electronically through the
NPDB Web site at https://www.npdbhipdb.hrsa.gov/. All reporting and
querying is performed through this
secure Web site.
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 ICR are
summarized in the table below.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
VerDate Mar<15>2010
1
38,785
.25
9,696
14,193
1
14,193
.75
10,645
28,700
1
28,700
.75
21,525
DEA/Federal Licensure ......
499
1
499
.75
374
Peer Review Organization ..
10
1
10
.75
8
Accreditation .......................
Title IV Clinical Privileges
Actions.
10
962
1
1
10
962
.75
.75
8
722
Professional Society ...........
§ 60.12: Reporting adverse
actions taken against clinical privileges.
38,785
71
1
71
.75
53
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Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
Number of
respondents
Regulation citation
Form name
§ 60.13: Reporting Federal
or State criminal convictions to the delivery of a
health care item or service.
Criminal Conviction (Guilty
Plea or Trial).
§ 60.14: Reporting civil
judgments related to the
delivery of a health care
item or service.
§ 60.15: Reporting exclusions from participation in
Federal or State health
care programs.
§ 60.16: Reporting other adjudicated actions or decisions.
§ 60.18 Requesting Information from the NPDB.
§ 60.21: How to dispute the
accuracy of NPDB information.
Administrative .....................
Hours per
response
Total burden
hours
1
1,023
.75
767
Deferred Conviction or PreTrial Diversion.
Nolo Contendere (No Contest) Plea.
Injunction ............................
Civil Judgment ....................
126
1
126
.75
95
63
1
63
.75
47
10
10
1
1
10
10
.75
.75
8
8
Exclusion/Debarment ..........
2,402
1
2,402
.75
1,802
Government Administrative
2,682
1
2,682
.75
2,012
561
986,552
1
1
561
986,552
.75
.08
421
78,924
18,892
1
18,892
.08
1,511
154,824
1,095
1
1
154,824
1,095
.42
.42
65,026
460
387,767
3,347
1
1
387,767
3,347
.08
.75
31,021
2,510
83
1
83
8
664
35,915
15,461
1
1
35,915
15,461
1
.08
35,915
1,237
100
100
1
1
100
100
.25
.25
25
25
562
1
562
.25
141
1,290
1
1,290
.25
323
20
1
20
.25
5
1,696,115
........................
1,696,115
........................
265,978
Health Plan Action ..............
One Time Query for an Individual.
One Time Query for an Organization.
Self-Query on an Individual
Self-Query on an Organization.
Continuous Query ...............
Subject Statement and Dispute.
Request for Secretarial Review.
Entity Registration (Initial) ..
Entity Registration (Renewal & Update).
Agent Registration (Initial) ..
Agent Registration (Renewal & Update).
Electronic Transfer of
Funds (EFT)Authorization.
Authorized Agent Designation.
Account Discrepancy ..........
.............................................
Submit your comments to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
mstockstill on DSK4VPTVN1PROD with NOTICES
Total
responses
1,023
Total .............................
Dated: April 1, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–08071 Filed 4–5–13; 8:45 am]
BILLING CODE 4165–15–P
VerDate Mar<15>2010
Responses
per
respondent
20:02 Apr 05, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Environmental
Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: May 14–15, 2013.
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20929-20931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08071]
-----------------------------------------------------------------------
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
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
Information Collection Request Title: National Practitioner Data Bank
for Adverse Information on Physicians and Other Health Care
Practitioners--45 CFR Part 60 Regulations and Forms OMB No. 0915-0126--
Revision
Abstract: This is a request for a revision of OMB approval of the
information collections contained in regulations found at 45 CFR part
60 governing the National Practitioner Data Bank (NPDB) and the forms
to be used in registering with, reporting information to, and
requesting information from the NPDB. Section 6403 of the Patient
Protection and Affordable Care Act of 2010 (Affordable Care Act) Public
Law 111-148 requires the transfer of all data in the Healthcare
Integrity and Protection Data Bank
[[Page 20930]]
(HIPDB) to the NPDB. Data collection will not change; however, the
merger will consolidate forms from OMB No. 0915-0239 for HIPDB under
OMB No. 0915-0126 for NPDB. Responsibility for NPDB implementation and
operation resides in the Bureau of Health Professions, Health Resources
and Services Administration (HRSA), Department of Health and Human
Services (HHS). Operation of the HIPDB was delegated by the HHS Office
of the Inspector General to HRSA. This rule eliminates duplicative data
reporting and access requirements between the HIPDB [established
through the Health Insurance Portability and Accountability Act of 1996
(HIPPA) under Section 1128(b)(5) of the Social Security Act (42 U.S.C.
1320a-7e)] and the NPDB [established through the Health Care Quality
Improvement Act of 1986 under Title IV (42 U.S.C. 11101 et seq.) and
expanded by Section 1921 of the Social Security Act (42 U.S.C. 1396r-
2)]. Information previously collected and disclosed through the HIPDB
will be collected and disclosed through the NPDB. Section 6403 of the
Affordable Care Act consolidates the collection and disclosure of
information from both data banks under Title 45 part 60 of the Code of
Federal Regulations (CFR). HHS will subsequently remove Title 45 part
61, which implemented the HIPDB.
The intent of NPDB is to improve the quality of health care by
encouraging hospitals, state licensing boards, professional societies,
and other entities providing health care services, to identify and
discipline those who engage in unprofessional behavior; and to restrict
the ability of incompetent health care practitioners, providers, or
suppliers to move from state to state without disclosure of previous
damaging or incompetent performance. It also serves as a fraud and
abuse clearinghouse for the reporting and disclosing of certain final
adverse actions (excluding settlements in which no findings of
liability have been made) taken against health care practitioners,
providers, or suppliers by health plans, federal agencies, and state
agencies.
The NPDB acts primarily as a flagging system; its principal purpose
is to facilitate comprehensive review of practitioners' professional
credentials and background. Information is collected from, and
disseminated to, eligible entities (entities that are entitled to query
and/or report to the NPDB under the three aforementioned statutory
authorities) on the following: (1) Medical malpractice payments, (2)
licensure actions taken by Boards of Medical Examiners, (3) state
licensure and certification actions, (4) federal licensure and
certification actions, (5) negative actions or findings taken by peer
review organizations or private accreditation entities, (6) adverse
actions taken against clinical privileges, (7) federal or state
criminal convictions related to the delivery of a health care item or
service, (8) civil judgments related to the delivery of a health care
item or service, (9) exclusions from participation in federal or state
health care programs, and (10) other adjudicated actions or decisions.
It is intended that NPDB information should be considered with other
relevant information in evaluating credentials of health care
practitioners, providers, and suppliers.
The reporting forms and the request for information forms (query
forms) are accessed, completed, and submitted to the NPDB
electronically through the NPDB Web site at https://www.npdb-hipdb.hrsa.gov/. All reporting and querying is performed through this
secure Web site.
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 ICR are summarized in the table below.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Regulation citation Form name respondents respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 60.6: Reporting errors, omissions, Correction, Revision to 38,785 1 38,785 .25 9,696
revisions or whether an action is on Action, Correction of
appeal. Revision to Action, Void,
Notice of Appeal.
Sec. 60.7: Reporting medical malpractice Medical Malpractice Payment. 14,193 1 14,193 .75 10,645
payments.
Sec. 60.8: Reporting licensure actions State Licensure............. 28,700 1 28,700 .75 21,525
taken by Boards of Medical Examiners &
Sec. 60.9: Reporting licensure and
certification actions taken by States.
Sec. 60.10: Reporting Federal licensure DEA/Federal Licensure....... 499 1 499 .75 374
and certification actions.
Sec. 60.11: Reporting negative actions Peer Review Organization.... 10 1 10 .75 8
or findings taken by peer review
organizations or private accreditation
entities.
Accreditation............... 10 1 10 .75 8
Sec. 60.12: Reporting adverse actions Title IV Clinical Privileges 962 1 962 .75 722
taken against clinical privileges. Actions.
Professional Society........ 71 1 71 .75 53
[[Page 20931]]
Sec. 60.13: Reporting Federal or State Criminal Conviction (Guilty 1,023 1 1,023 .75 767
criminal convictions to the delivery of a Plea or Trial).
health care item or service.
Deferred Conviction or Pre- 126 1 126 .75 95
Trial Diversion.
Nolo Contendere (No Contest) 63 1 63 .75 47
Plea.
Injunction.................. 10 1 10 .75 8
Sec. 60.14: Reporting civil judgments Civil Judgment.............. 10 1 10 .75 8
related to the delivery of a health care
item or service.
Sec. 60.15: Reporting exclusions from Exclusion/Debarment......... 2,402 1 2,402 .75 1,802
participation in Federal or State health
care programs.
Sec. 60.16: Reporting other adjudicated Government Administrative... 2,682 1 2,682 .75 2,012
actions or decisions.
Health Plan Action.......... 561 1 561 .75 421
Sec. 60.18 Requesting Information from One Time Query for an 986,552 1 986,552 .08 78,924
the NPDB. Individual.
One Time Query for an 18,892 1 18,892 .08 1,511
Organization.
Self-Query on an Individual. 154,824 1 154,824 .42 65,026
Self-Query on an 1,095 1 1,095 .42 460
Organization.
Continuous Query............ 387,767 1 387,767 .08 31,021
Sec. 60.21: How to dispute the accuracy Subject Statement and 3,347 1 3,347 .75 2,510
of NPDB information. Dispute.
Request for Secretarial 83 1 83 8 664
Review.
Administrative............................ Entity Registration 35,915 1 35,915 1 35,915
(Initial).
Entity Registration (Renewal 15,461 1 15,461 .08 1,237
& Update).
Agent Registration (Initial) 100 1 100 .25 25
Agent Registration (Renewal 100 1 100 .25 25
& Update).
Electronic Transfer of Funds 562 1 562 .25 141
(EFT)Authorization.
Authorized Agent Designation 1,290 1 1,290 .25 323
Account Discrepancy......... 20 1 20 .25 5
-------------------------------------------------------------------------------------------------------------
Total................................. ............................ 1,696,115 .............. 1,696,115 .............. 265,978
--------------------------------------------------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
Deadline: Comments on this ICR should be received within 30 days of
this notice.
Dated: April 1, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-08071 Filed 4-5-13; 8:45 am]
BILLING CODE 4165-15-P
