Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals, 10647-10648 [05-4159]
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10647
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
In compliance with the requirements
of Section 3506(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 Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
grjohnson@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.
Dated: February 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–4236 Filed 3–3–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reports of Corrections and Removals—
21 CFR Part 806 (OMB Control Number
0910–0359)—Extension
Food and Drug Administration
The collection of information required
under the reports of corrections and
removals, part 806 (21 CFR part 806),
implements section 519(f) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360i(f)), as amended by the
Food and Drug Administration
Modernization Act of 1997 (FDAMA)
(21 U.S.C. 301) (Public Law 105–115).
Each device manufacturer or importer
under § 806.10 shall submit a written
report to FDA of any action initiated to
correct or remove a device to reduce a
risk to health posed by the device, or to
remedy a violation of the act caused by
the device which may present a risk to
health, within 10 working days of
initiating such correction or removal.
Each device manufacturer or importer
of a device who initiates a correction or
removal of a device that is not required
to be reported to FDA under § 806.20
shall keep a record of such correction or
removal.
The information collected in the
reports of corrections and removals will
be used by FDA to identify marketed
devices that have serious problems and
to ensure that defective devices are
removed from the market. This will
assure that FDA has current and
complete information regarding these
corrections and removals and to
determine whether recall action is
adequate.
In the Federal Register of December
14, 2004 (69 FR 74527), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents to this collection of
information are manufacturers and
importers of medical devices.
FDA estimates the burden of this
collection of information as follows:
[Docket No. 2004N–0525]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reports of
Corrections and Removals
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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
ADDRESSES:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
806.10
Annual Frequency per
Response
482
Total Annual
Responses
1
482
Hours per
Respondent
10
Totals
1There
Total Hours
4,820
4,820
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
806.20
Annual Frequency per
Record
143
Total Annual
Records
1
143
Totals
1There
Hours per
Recordkeeper
10
Total Hours
1,430
1,430
are no capital costs or operating and maintenance costs associated with this collection of information.
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10648
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
In 2001, when preparing the earlier
package for approval of the information
collection requirements in part 806,
FDA reviewed the reports of corrections
and removals submitted in the previous
3 years under part 7 (21 CFR part 7) (the
agency’s recall provisions). FDA has
determined that estimates of the
reporting burden in §§ 806.10 and
806.20 should be revised to reflect a
reduction of 29 percent for reports and
records submitted under part 7 due to
a decrease in recall actions. The time
needed to collect information has been
reduced by 4 hours per record due to
the implementation of a computerized
program for information collection
requirements in part 806.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4159 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0401]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Customer/Partner
Service Surveys
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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
ADDRESSES:
Customer/Partner Service Surveys—
(OMB Control Number 0910–0360)—
Extension
Under section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the agency. Executive
Order 12862, entitled ‘‘Setting Customer
Service Standard,’’ directs Federal
agencies that ‘‘provide significant
services directly to the public’’ to
‘‘survey customers to determine the
kind and quality of services they want
and their level of satisfaction with
existing services.’’ FDA is seeking OMB
clearance to conduct a series of surveys
to implement Executive Order 12862.
Participation in the surveys is
voluntary. This request covers
customer/partner service surveys of
regulated entities, such as the following:
Food processors; cosmetic drug, biologic
and medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA projects that approximately 15
customer/partner service surveys will be
conducted per year, with a sample of
between 50 and 6,000 customers,
requiring an average of 18 minutes for
review and completion for each survey.
Some of these surveys will be repeats of
earlier surveys, for purposes of
monitoring customer/partner service
and developing long-term data.
In the Federal Register of September
16, 2004 (69 FR 55823), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Type of Survey
No. of Respondents
Mail/telephone/fax/web-based
1There
Annual Frequency per
Response
15,000
Total Annual
Responses
1
15,000
Hours per Respondent
.30
Total Hours
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4160 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0498]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Medical Devices; Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
ADDRESSES:
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10647-10648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0525]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reports of
Corrections and Removals
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 April
4, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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.
Reports of Corrections and Removals--21 CFR Part 806 (OMB Control
Number 0910-0359)--Extension
The collection of information required under the reports of
corrections and removals, part 806 (21 CFR part 806), implements
section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360i(f)), as amended by the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105-115).
Each device manufacturer or importer under Sec. 806.10 shall
submit a written report to FDA of any action initiated to correct or
remove a device to reduce a risk to health posed by the device, or to
remedy a violation of the act caused by the device which may present a
risk to health, within 10 working days of initiating such correction or
removal.
Each device manufacturer or importer of a device who initiates a
correction or removal of a device that is not required to be reported
to FDA under Sec. 806.20 shall keep a record of such correction or
removal.
The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and to ensure that defective devices are removed from
the market. This will assure that FDA has current and complete
information regarding these corrections and removals and to determine
whether recall action is adequate.
In the Federal Register of December 14, 2004 (69 FR 74527), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Respondents to this collection of information are manufacturers and
importers of medical devices.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
806.10 482 1 482 10 4,820
----------------------------------------------------------------------------------------------------------------
Totals .............. ....................... .............. .............. 4,820
----------------------------------------------------------------------------------------------------------------
\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 per Total Annual Hours per
21 CFR Section Recordkeepers Record Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
806.20 143 1 143 10 1,430
----------------------------------------------------------------------------------------------------------------
Totals .............. ....................... .............. .............. 1,430
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 10648]]
In 2001, when preparing the earlier package for approval of the
information collection requirements in part 806, FDA reviewed the
reports of corrections and removals submitted in the previous 3 years
under part 7 (21 CFR part 7) (the agency's recall provisions). FDA has
determined that estimates of the reporting burden in Sec. Sec. 806.10
and 806.20 should be revised to reflect a reduction of 29 percent for
reports and records submitted under part 7 due to a decrease in recall
actions. The time needed to collect information has been reduced by 4
hours per record due to the implementation of a computerized program
for information collection requirements in part 806.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4159 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S
