Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 59775-59776 [2014-23551]
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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
potential sponsors must meet certain
conditions pursuant to section 462 of
the Homeland Security Act and the
Flores v. Reno Settlement Agreement
No. CV85–4544–RJK (C.D. Cal. 1997).
The proposed information collection
requests information to be utilized by
ORR for determining the suitability of a
sponsor/respondent for the release of a
minor from ORR custody. The proposed
instruments are the Family
Reunification Application, the Family
Reunification Checklist for Sponsors,
and the Authorization for Release of
Information.
Respondents: Sponsors requesting
release of unaccompanied alien children
to their custody.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
mstockstill on DSK4VPTVN1PROD with NOTICES
Family Reunification Application ......................................................................
Family Reunification Checklist for Sponsors ...................................................
Authorization for Release of Information .........................................................
Estimated Total Annual Burden
Hours: 69,000.
ORR has requested emergency
processing for this information
collection for a period of 90 days from
the October 31, 2014 expiration date of
these instruments.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–23581 Filed 10–2–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0076]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
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 November
3, 2014.
ADDRESSES: To ensure that comments on
the information collection are received,
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 0910–0303. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
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Number of
responses per
respondent
1
1
1
Average
burden hours
per response
.25
.75
.25
Total burden
hours
13,800
41,400
13,800
Electronic Records; Electronic
Signatures—(OMB Control Number
0910–0303)—Extension
FDA regulations in part 11 (21 CFR
part 11) provide criteria for acceptance
of electronic records, electronic
signatures, and handwritten signatures
executed to electronic records as
equivalent to paper records. Under these
regulations, records and reports may be
submitted to FDA electronically
provided the Agency has stated its
ability to accept the records
electronically in an Agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require the following standard operating
procedures to assure appropriate use of,
and precautions for, systems using
electronic records and signatures: (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify in writing to FDA that
they will regard electronic signatures
used in their systems as the legally
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The Agency anticipates the
use of electronic media will
substantially reduce the paperwork
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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
burden associated with maintaining
FDA required records. The respondents
are businesses and other for-profit
organizations, state or local
governments, Federal Agencies, and
nonprofit institutions.
In the Federal Register of March 28,
2014 (79 FR 17551), 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 REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
11.100—General Requirements ..........................................
4,500
1
4,500
1
4,500
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
11.10—Controls for closed systems ....................................
11.30—Controls for open systems ......................................
11.50—Signature manifestations .........................................
11.300—Controls for identification codes/passwords ..........
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 29, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
by which FDA intends to phase in
enforcement of FDA regulatory
requirements for LDTs over time. This
draft guidance is not final, nor is it in
effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 2,
2015.
[FR Doc. 2014–23551 Filed 10–2–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0360]
Framework for Regulatory Oversight of
Laboratory Developed Tests; Draft
Guidance for Industry, Food and Drug
Administration Staff, and Clinical
Laboratories; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Framework for Regulatory
Oversight of Laboratory Developed Tests
(LDTs).’’ This document describes a
risk-based framework for addressing the
regulatory oversight of a subset of in
vitro diagnostic devices (IVDs) referred
to as laboratory developed tests (LDTs),
which are intended for clinical use and
designed, manufactured and used
within a single laboratory. This
document describes FDA’s priorities for
enforcing pre- and post-market
requirements for LDTs, and the process
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SUMMARY:
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An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for
single hard copies of the draft guidance
document entitled ‘‘Framework for
Regulatory Oversight of Laboratory
Developed Tests (LDTs)’’ to the Office of
the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health (CDRH), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request. The guidance may also be
ADDRESSES:
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obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800.
Submit electronic comments on the
draft guidance 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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
LDTframework@fda.hhs.gov; or
Katherine Serrano, Center for Devices
and Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 5646,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 240–402–4217;
or Stephen Ripley, Center for Biologics
Evaluation and Research Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
In 1976, Congress enacted the Medical
Device Amendments (MDA), which
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to create
a comprehensive system for the
regulation of medical devices intended
for use in humans. At that time, the
definition of a device was amended to
make explicit that it encompassed in
vitro diagnostic devices (IVDs): ‘‘The
term ‘device’. . . means an instrument,
apparatus, implement, machine,
contrivance, implant, in vitro reagent, or
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[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Pages 59775-59776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23551]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0076]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Records;
Electronic Signatures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
November 3, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, 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 0910-0303.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Electronic Records; Electronic Signatures--(OMB Control Number 0910-
0303)--Extension
FDA regulations in part 11 (21 CFR part 11) provide criteria for
acceptance of electronic records, electronic signatures, and
handwritten signatures executed to electronic records as equivalent to
paper records. Under these regulations, records and reports may be
submitted to FDA electronically provided the Agency has stated its
ability to accept the records electronically in an Agency-established
public docket and that the other requirements of part 11 are met.
The recordkeeping provisions in part 11 (Sec. Sec. 11.10, 11.30,
11.50, and 11.300) require the following standard operating procedures
to assure appropriate use of, and precautions for, systems using
electronic records and signatures: (1) Sec. 11.10 specifies procedures
and controls for persons who use closed systems to create, modify,
maintain, or transmit electronic records; (2) Sec. 11.30 specifies
procedures and controls for persons who use open systems to create,
modify, maintain, or transmit electronic records; (3) Sec. 11.50
specifies procedures and controls for persons who use electronic
signatures; and (4) Sec. 11.300 specifies controls to ensure the
security and integrity of electronic signatures based upon use of
identification codes in combination with passwords. The reporting
provision (Sec. 11.100) requires persons to certify in writing to FDA
that they will regard electronic signatures used in their systems as
the legally binding equivalent of traditional handwritten signatures.
The burden created by the information collection provision of this
regulation is a one-time burden associated with the creation of
standard operating procedures, validation, and certification. The
Agency anticipates the use of electronic media will substantially
reduce the paperwork
[[Page 59776]]
burden associated with maintaining FDA required records. The
respondents are businesses and other for-profit organizations, state or
local governments, Federal Agencies, and nonprofit institutions.
In the Federal Register of March 28, 2014 (79 FR 17551), 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 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100--General Requirements....................................... 4,500 1 4,500 1 4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
11.10--Controls for closed 2,500 1 2,500 20 50,000
systems........................
11.30--Controls for open systems 2,500 1 2,500 20 50,000
11.50--Signature manifestations. 4,500 1 4,500 20 90,000
11.300--Controls for 4,500 1 4,500 20 90,000
identification codes/passwords.
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 280,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 29, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-23551 Filed 10-2-14; 8:45 am]
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