Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 40378-40379 [2011-17155]
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40378
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
reasonable assurance of the safety and
effectiveness of such devices. In
December 2000, Congress enacted
Public Law 106–554, which among
other provisions, directed FDA to
‘‘reexamine existing condom labels’’
and ‘‘determine whether the labels are
medically accurate regarding the overall
effectiveness or lack of effectiveness in
preventing sexually transmitted diseases
* * *.’’ In response, FDA recommended
labeling intended to provide important
information for condom users, including
the extent of protection provided by
condoms against various types of
sexually transmitted diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden
per disclosure
Total hours
884.5300 ..............................................................................
3
34
102
12
1,224
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA expects approximately three new
manufacturers or repackagers to enter
the market yearly, and collectively have
a third party disclosure burden of 1,224
hours. The number of respondents and
prospective new manufacturers cited in
table 1 of this document are based on
FDA’s database of premarket
submissions. The remaining figures
were derived from a study performed for
FDA by Eastern Research Group, Inc., an
economic consulting firm, to estimate
the impact of the 1999 over-the-counter
(OTC) human drug labeling
requirements final rule (64 FR 13254,
March 17, 1999). Because the packaging
requirements for condoms are similar to
those of many OTC drugs, we believe
the burden to design the labeling for
OTC drugs is an appropriate proxy for
the estimated burden to design condom
labeling.
The special controls guidance
document also refers to currently
approved collections of information
found in FDA regulations. The
collections of information under 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
the collections of information under 21
CFR part 820 have been approved under
OMB control number 0910–0073; and
the collections of information in part
801 (21 CFR part 801) have been
approved under OMB control number
0910–0485.
The collection of information under
§ 801.437 does not constitute a
‘‘collection of information’’ under the
PRA. Rather, it is a ‘‘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)).
Dated: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17156 Filed 7–7–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Electronic Records; Electronic
Signatures—(OMB Control Number
0910–0303)—Revision
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 (21 CFR 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.
In the Federal Register of February
16, 2011 (76 FR 9024), FDA published
a 60-day notice requesting public
comment on the proposed collection of
[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 August 8,
2011.
SUMMARY:
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 e-mailed 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.
ADDRESSES:
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
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40379
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
information. FDA received one
comment which was related to the
Paperwork Reduction Act burden
associated with this collection of
information.
The comment indicated that table 2 in
the 60-day notice was not clear if it
represented burden for all respondents,
or just one respondent. In addition, the
commenter noted that if table 2
represented the estimated burden for all
respondents, that they did not agree
with the accuracy of FDA’s estimate, as
the table appears to assume that each
respondent creates one SOP per each
21 CFR section listed. The commenter
felt that this assumption is not correct
for large companies, who could possibly
have several thousand systems, each
requiring their own SOPs. If this were
burden adequately represents the
average burden a firm might expend to
complete the recordkeeping
requirements for this collection.
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. The respondents
will be businesses and other for-profit
organizations, State or local
governments, Federal Agencies, and
nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
the case, the recordkeeping burden in
Table 2 would be severely understated.
FDA’s response is to note that the
recordkeeping burden in table 2 is an
estimate of both large and small firms,
and the burden represented in the table
is an average of the burden for all forms.
In addition, the recordkeeping
requirements ask each respondent to
this collection maintain a set of SOPs
which could help the company and
FDA in the future determine the
methodology the company employed in
its systems to ensure that the electronic
signatures for its employees on
documents submitted to the FDA were
valid, if needed. Over the years, FDA
developed this recordkeeping burden by
listening to feedback from its staff and
external stakeholders, and feels that the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
11,100 ..................................................................................
4,500
1
4,500
1
4,500
Total ..............................................................................
........................
........................
........................
........................
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
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
11.10 ....................................................................................
11.30 ....................................................................................
11.50 ....................................................................................
11.300 ..................................................................................
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: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17155 Filed 7–7–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
New Proposed Collection; Comment
Request; Study Logistic Formative
Research Methodology Studies for the
National Children’s Study
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
SUMMARY:
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National Institute of Child Health and
Human Development (NIHCD), the
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. This proposed
information collection was previously
published in the Federal Register on
April 27, 2011, pages 23605–23606, and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
Proposed Collection
Title: Study Logistics Formative
Research Methodology Studies for the
National Children’s Study (NCS).
Type of Information Collection
Request: Generic Clearance.
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Need and Use of Information
Collection: The Children’s Health Act of
2000 (Pub. L. 106–310) states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
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[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40378-40379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17155]
-----------------------------------------------------------------------
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 August
8, 2011.
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 e-mailed 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: 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.
Electronic Records; Electronic Signatures--(OMB Control Number 0910-
0303)--Revision
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 (21 CFR 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.
In the Federal Register of February 16, 2011 (76 FR 9024), FDA
published a 60-day notice requesting public comment on the proposed
collection of
[[Page 40379]]
information. FDA received one comment which was related to the
Paperwork Reduction Act burden associated with this collection of
information.
The comment indicated that table 2 in the 60-day notice was not
clear if it represented burden for all respondents, or just one
respondent. In addition, the commenter noted that if table 2
represented the estimated burden for all respondents, that they did not
agree with the accuracy of FDA's estimate, as the table appears to
assume that each respondent creates one SOP per each 21 CFR section
listed. The commenter felt that this assumption is not correct for
large companies, who could possibly have several thousand systems, each
requiring their own SOPs. If this were the case, the recordkeeping
burden in Table 2 would be severely understated.
FDA's response is to note that the recordkeeping burden in table 2
is an estimate of both large and small firms, and the burden
represented in the table is an average of the burden for all forms. In
addition, the recordkeeping requirements ask each respondent to this
collection maintain a set of SOPs which could help the company and FDA
in the future determine the methodology the company employed in its
systems to ensure that the electronic signatures for its employees on
documents submitted to the FDA were valid, if needed. Over the years,
FDA developed this recordkeeping burden by listening to feedback from
its staff and external stakeholders, and feels that the burden
adequately represents the average burden a firm might expend to
complete the recordkeeping requirements for this collection.
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. The respondents will be businesses and other for-profit
organizations, State or local governments, Federal Agencies, and
nonprofit institutions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
11,100.......................... 4,500 1 4,500 1 4,500
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (in 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: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17155 Filed 7-7-11; 8:45 am]
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