Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 36537-36538 [E8-14659]
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Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
This regulation also refers to
previously approved collections of
information found in FDA regulations.
The collections of information under
§§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; the collections of
information under § 800.12(e) have been
approved under OMB control number
0910–0231; and the collections of
information under § 801.435(g) have
been approved under OMB control
number 0910–0073.
Further, FDA concludes that labeling
statements under §§ 801.63;
801.405(b)(2) and (b)(3); 801.420(c)(2)
and (c)(3); 801.430(c) and(e)(1); 801.433;
801.437(d) through (g); 809.30(d)(2),
(d)(3), and (e) do not constitute a
‘‘collection of information’’ under the
PRA. Rather, these labeling statements
are ‘‘public disclosure’’ of information
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)).
jlentini on PROD1PC65 with NOTICES
Reporting
These estimates are based on FDA’s
registration and listing database for
medical device establishments, agency
communications with industry, and
FDA’s knowledge of, and experience
with device labeling.
Recordkeeping
These estimates are based on FDA’s
registration and listing database for
medical device establishments, agency
communications with industry, and
FDA’s knowledge of and experience
with device labeling. In addition, the
Vision Council of America provided the
growth rate used to estimate the burden
under § 801.410(e) and (f).
FDA is correcting its recordkeeping
burden estimate for § 801.410(e) and (f).
In the Federal Register of April 23,
2008, the recordkeeping burden
estimate in Table 2 was overestimated
as 11,935,028 hours. The corrected
recordkeeping burden estimate for this
proposed collection is 422,686 hours.
The correction for the recordkeeping
burden estimate was necessary due to
two errors. First, FDA incorrectly gave
an estimate of 0.25 hours per
recordkeeper for § 801.410(e) and (f).
The corrected estimate is 0.0008 hours
per recordkeeper. Secondly, FDA
inadvertently duplicated the
recordkeeping burden for these sections.
This regulation also refers to
previously approved collections of
information found in FDA regulations.
The collections of information under
§§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; and the collections of
VerDate Aug<31>2005
18:47 Jun 26, 2008
Jkt 214001
information under § 800.12(e) have been
approved under OMB control number
0910–0231.
The information collection
requirements under §§ 801.22, 801.63,
801.405(b)(2) and (b)(3), 801.420(c)(2)
and (c)(3), 801.430(c) and (e)(1),
801.433, 801.437(d) through (g);
809.30(d)(2), (d)(3), and (e) are not
considered information collection
because the public information is
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public (5
CFR 1320.3(c)(2)).
We have not estimated a burden for
information that is disclosed to third
parties, because it is a ‘‘usual and
customary’’ part of a medical device
manufacturer, distributor, or importer’s
normal business activities. Nor have we
estimated a burden for time that is spent
designing labels to improve the format
or presentation.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14658 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0168]
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 July 28,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0303. Also
ADDRESSES:
PO 00000
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36537
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Electronic Records; Electronic
Signatures—(OMB Control Number
0910–0303)—Extension
The 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 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
burden associated with maintaining
FDA required records.
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36538
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
The respondents will be businesses
and other for-profit organizations, State
or local governments, Federal agencies,
and nonprofit institutions.
In the Federal Register of March 26,
2008 (73 FR 16017), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
11.100
1There
Annual Frequency
per Response
4,500
Total Annual
Responses
1
Hours per
Response
4,500
Total Hours
1
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
11.10
2,500
1
2,500
20
50,000
11.30
2,500
1
2,500
20
50,000
11.50
4,500
1
4,500
20
90,000
11.300
4,500
1
4,500
20
90,000
Total
1There
280,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14659 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jlentini on PROD1PC65 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, Core
Instrumentation.
Date: July 14–15, 2008.
Time: 8 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
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18:47 Jun 26, 2008
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Joseph D. Mosca, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5158,
MSC 7808, Bethesda, MD 20892, 301–435–
2344, moscajos@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Dermatology/Rheumatology Small Business,
Special Emphasis Panel.
Date: July 18–22, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Daniel F. McDonald, PhD,
Scientific Review Officer, Chief, MOSS IRG,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 4214, MSC 7814, Bethesda, MD 20892,
(301) 435–1215, mcdonald@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Cancer
Biology.
Date: July 18, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
PO 00000
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Contact Person: Denise R. Shaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892, 301–435–
0198, shawkath@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Discovery of
Novel Epigenetic Marks.
Date: July 25, 2008.
Time: 8 a.m. to 9 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Richard Panniers, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2212,
MSC 7890, Bethesda, MD 20892, (301) 435–
1741, pannierr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Sharing
Data and Tools and Data Ontologies.
Date: July 28, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Alexander Gubin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5144,
MSC 7812, Bethesda, MD 20892, 301–435–
2902, gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Drug Abuse
Aspects of HIV/AIDS.
E:\FR\FM\27JNN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36537-36538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0168]
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 July
28, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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
The 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 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 burden associated with maintaining FDA required
records.
[[Page 36538]]
The respondents will be businesses and other for-profit
organizations, State or local governments, Federal agencies, and
nonprofit institutions.
In the Federal Register of March 26, 2008 (73 FR 16017), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.10 2,500 1 2,500 20 50,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.30 2,500 1 2,500 20 50,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.50 4,500 1 4,500 20 90,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.300 4,500 1 4,500 20 90,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 280,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14659 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S
