Agency Information Collection Activities: Proposed Collection; Comment Request, 9394-9395 [2013-02905]
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9394
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices
Community as a Learning Health System.
Committee members will consider ways to
implement components of the graphic on the
Influences on the Population’s Health, in the
Shaping a Health Statistics Vision for the
21st Century report. The Co-chairs for the
Privacy, Confidentiality and Security
Subcommittee will brief the Committee about
an upcoming hearing to obtain input about
implementing health data stewardship, and
the Standards and Quality Subcommittees
will also provide updates on plans and
activities.
On the morning of the second day, the
Committee will continue to discuss ways to
promote alignment throughout the
Committee to enhance its effectiveness, focus
on its themes, and utilize expertise of the
NCVHS Working Group on HHS Data Access
and Use. Once the full Committee adjourns,
the NCVHS’s Working Group on HHS Data
Access and Use will convene to discuss best
practices and suggestions to further the
dissemination and use of open HHS data, and
summarize future plans of the Working
Group. Further information will be provided
on the NCVHS Web site at https://
www.ncvhs.hhs.gov/.
The times shown above are for the full
Committee meeting. Subcommittee breakout
sessions are scheduled for late in the
afternoon on the first day. Agendas for these
breakout sessions will be posted on the
NCVHS Web site (URL below) when
available.
Contact Person for More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Marjorie S. Greenberg, Executive Secretary,
NCVHS, National Center for Health Statistics,
Centers for Disease Control and Prevention,
3311 Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Dated: January 31, 2013.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2013–02830 Filed 2–7–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10419]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: New collection (request for a
new OMB control number). Title of
Information Collection: Transparency
Reports and Reporting of Physician
Ownership or Investment Interests. Use:
Reports of Payments or Other Transfers
of Value to Covered Recipients.
Section 403.904 requires direct and
indirect payments or other transfers of
value provided by an applicable
manufacturer to a covered recipient, and
that direct and indirect payments or
other transfers of value provided to a
third party at the request of (or
designated by) the applicable
manufacturer on behalf of a covered
recipient, be reported by the applicable
manufacturer to CMS on an annual
basis.
AGENCY:
Reports of Physician Ownership and
Investment Interests
Under § 403.906, each applicable
manufacturer and applicable group
purchasing organization must report to
CMS on an annual basis all ownership
and investment interests in the
applicable manufacturer or applicable
group purchasing organization that were
held by a physician or an immediate
family member of a physician during
the preceding calendar year.
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Data Collection
The data templates will provide
detailed information about the data to
be collected including the data element
name, format, allowable values,
required versus optional fields, and
other associated rules intended to aid
the applicable manufacturers and
applicable group purchasing
organizations as they prepare for and
participate in data collection.
Applicable manufacturers and
applicable GPOs will engage in data
collection external to CMS within their
own systems or tracking tools. If we
intend to make changes to the data
templates, we will provide them at least
90 days prior to first day of data
collection for the next reporting year. In
providing revised templates, we will
also comply with the requirements of
the Paperwork Reduction Act to seek
public comments on the proposed
changes to the information collections,
as required by law. This will allow
applicable manufacturers and
applicable GPOs to make any necessary
changes to prepare for the next reporting
year. This is the same time as the date
by which we will publish the list of
teaching hospitals.
Data Submission Procedures for
Electronic Submission of Reports
Section 403.908 requires that reports
must be electronically submitted to
CMS by March 31, 2014, and by the
90th day of each subsequent calendar
year. Form Number: CMS–10461 (OCN
0938—New). Frequency: Annual.
Affected Public: Private Sector (business
or other for-profit and not-for-profit
institutions). Number of Respondents:
396,514. Total Annual Responses:
396,514. Total Annual Hours:
13,327,065. (For policy questions
regarding this collection contact Erica
Breese at 202–260–6079. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by April 9, 2013:
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9395
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number _________, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: February 5, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–02905 Filed 2–7–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0560]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 11,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0582. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—(OMB
Control Number 0910–0582)—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812, Investigational
Device Exemptions, under 21 CFR
812.2(c)(3), but FDA’s regulations for
the protection of human subjects (21
CFR parts 50 and 56) apply to all
clinical investigations that are regulated
by FDA (see 21 CFR 50.1, 21 CFR
56.101, 21 U.S.C. 360j(g)(3)(A), and 21
U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level 1 guidance document,
entitled ‘‘Guidance on Informed
Consent for In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens That Are Not Individually
Identifiable,’’ issued under the Good
Guidances Practices regulation, 21 CFR
10.115, FDA outlines the circumstances
in which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
The recommendations of the guidance
impose a minimal burden on industry.
FDA estimates that 700 studies will be
affected annually. Each study will result
in one annual record, estimated to take
4 hours to complete. This results in a
total recordkeeping burden of 2,800
hours (700 × 4 = 2,800).
In the Federal Register of June 12,
2012 (77 FR 34954), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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Federal Food, Drug, and Cosmetic Act Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
520(g) (21 U.S.C. 360j(g)) ...................................................
700
1
700
4
2,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9394-9395]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10419]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
1. Type of Information Collection Request: New collection (request
for a new OMB control number). Title of Information Collection:
Transparency Reports and Reporting of Physician Ownership or Investment
Interests. Use: Reports of Payments or Other Transfers of Value to
Covered Recipients.
Section 403.904 requires direct and indirect payments or other
transfers of value provided by an applicable manufacturer to a covered
recipient, and that direct and indirect payments or other transfers of
value provided to a third party at the request of (or designated by)
the applicable manufacturer on behalf of a covered recipient, be
reported by the applicable manufacturer to CMS on an annual basis.
Reports of Physician Ownership and Investment Interests
Under Sec. 403.906, each applicable manufacturer and applicable
group purchasing organization must report to CMS on an annual basis all
ownership and investment interests in the applicable manufacturer or
applicable group purchasing organization that were held by a physician
or an immediate family member of a physician during the preceding
calendar year.
Data Collection
The data templates will provide detailed information about the data
to be collected including the data element name, format, allowable
values, required versus optional fields, and other associated rules
intended to aid the applicable manufacturers and applicable group
purchasing organizations as they prepare for and participate in data
collection. Applicable manufacturers and applicable GPOs will engage in
data collection external to CMS within their own systems or tracking
tools. If we intend to make changes to the data templates, we will
provide them at least 90 days prior to first day of data collection for
the next reporting year. In providing revised templates, we will also
comply with the requirements of the Paperwork Reduction Act to seek
public comments on the proposed changes to the information collections,
as required by law. This will allow applicable manufacturers and
applicable GPOs to make any necessary changes to prepare for the next
reporting year. This is the same time as the date by which we will
publish the list of teaching hospitals.
Data Submission Procedures for Electronic Submission of Reports
Section 403.908 requires that reports must be electronically
submitted to CMS by March 31, 2014, and by the 90th day of each
subsequent calendar year. Form Number: CMS-10461 (OCN 0938--New).
Frequency: Annual. Affected Public: Private Sector (business or other
for-profit and not-for-profit institutions). Number of Respondents:
396,514. Total Annual Responses: 396,514. Total Annual Hours:
13,327,065. (For policy questions regarding this collection contact
Erica Breese at 202-260-6079. For all other issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995,
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by April 9, 2013:
[[Page 9395]]
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address:
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ------------------, Room C4-26-05, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
Dated: February 5, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-02905 Filed 2-7-13; 8:45 am]
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