Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices, 2871-2872 [2010-795]
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2871
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–793 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0474]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 0910–0510. 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 (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 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.
ADDRESSES:
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 February
18, 2010.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—(OMB Control Number 0910–
0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons) to conduct
inspections of eligible manufacturers of
class II or class III devices. This is a
voluntary program. FDA has a guidance
document that provides information for
those interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
In the Federal Register of October 22,
2009 (74 FR 54570), 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 BURDEN1
Section of the Act
704(g)
No. of
Respondents
Item
Request for Accreditation
Annual Frequency
per Response
3
Total Annual
Responses
1
3
Hours per
Response
Total Hours
80
Total Hours
1 There
240
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
ACTION:
[FR Doc. 2010–796 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2009–N–0475]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Administrative
Detention and Banned Medical Devices
AGENCY:
240
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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 February
18, 2010.
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 0910–0114. Also
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
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:
Administrative Detention and Banned
Medical Devices—(OMB Control
Number 0910–0114)—Extension
FDA has the statutory authority under
section 304(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
E:\FR\FM\19JAN1.SGM
19JAN1
2872
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
334(g)), to detain during established
inspections, devices that are believed to
be adulterated or misbranded. FDA
issued a final rule that published in a
March 9, 1979, Federal Register (44 FR
13234) on administrative detention
procedures, which includes among
other things, certain reporting
requirements and recordkeeping
requirements under § 800.55(g) and (k),
(21 CFR 800.55(g) and (k)). Under
§ 800.55(g), an applicant of a detention
order must show documentation of
ownership if devices are detained at a
place other than that of the appellant.
Under § 800.55(k), the owner or other
responsible person must supply records
about how the devices may have
become adulterated or misbranded, in
addition to records of distribution of the
detained devices. These recordkeeping
requirements for administrative
detentions permits FDA to trace devices
for which the detention period expired
before a seizure is accomplished or
injunctive relief is obtained.
FDA also has the statutory authority
under section 516 of the act (21 U.S.C.
360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. The final rule for
banned devices that published in the
May 18, 1979, Federal Register (44 FR
29221) contained certain reporting
requirements under 21 CFR 895.21(d)
and 895.22(a). Section 895.21(d) states
that if the Commissioner of Food and
Drugs (the Commissioner), decides to
initiate a proceeding to make a device,
‘‘a banned device,’’ a notice of proposed
rulemaking will be published in the
Federal Register and this document will
contain the finding that the device
presents a substantial deception or an
unreasonable and substantial risk of
illness or injury. The document will
also contain the reasons why the
proceeding was initiated, an evaluation
of data and information obtained under
other provisions of the act, any
consultations with the panel, and a
determination as to whether the device
could be corrected by labeling, change
of labeling, change of advertising, and if
that labeling or change of advertising
has been made. Under § 895.21(d), any
interested person may request an
informal hearing and submit written
comments. Under § 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
three firms whose devices had been
detained.
In the Federal Register of October 16,
2009 (74 FR 53257), 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 BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
800.55(g)
Total Annual
Responses
Hours per
Response
Total Hours
1
1
25
25
26
895.21(d) and 895.22(a)
1
1
26
16
416
Totals
1 There
441
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
800.55(k)
Annual Frequency
per Recordkeeping
1
Total Annual
Records
1
Hours per
Recordkeeper
1
20
Totals
1 There
20
461
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–795 Filed 1–15–10; 8:45 am]
[Docket No. FDA–2009–N–0484]
BILLING CODE 4160–01–S
jlentini on DSKJ8SOYB1PROD with NOTICES
Total Hours
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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 February
18, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2871-2872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0475]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Administrative
Detention and Banned Medical Devices
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
February 18, 2010.
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 0910-0114.
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 (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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.
Administrative Detention and Banned Medical Devices--(OMB Control
Number 0910-0114)--Extension
FDA has the statutory authority under section 304(g) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
[[Page 2872]]
334(g)), to detain during established inspections, devices that are
believed to be adulterated or misbranded. FDA issued a final rule that
published in a March 9, 1979, Federal Register (44 FR 13234) on
administrative detention procedures, which includes among other things,
certain reporting requirements and recordkeeping requirements under
Sec. 800.55(g) and (k), (21 CFR 800.55(g) and (k)). Under Sec.
800.55(g), an applicant of a detention order must show documentation of
ownership if devices are detained at a place other than that of the
appellant. Under Sec. 800.55(k), the owner or other responsible person
must supply records about how the devices may have become adulterated
or misbranded, in addition to records of distribution of the detained
devices. These recordkeeping requirements for administrative detentions
permits FDA to trace devices for which the detention period expired
before a seizure is accomplished or injunctive relief is obtained.
FDA also has the statutory authority under section 516 of the act
(21 U.S.C. 360f) to ban devices that present substantial deception or
an unreasonable and substantial risk of illness or injury. The final
rule for banned devices that published in the May 18, 1979, Federal
Register (44 FR 29221) contained certain reporting requirements under
21 CFR 895.21(d) and 895.22(a). Section 895.21(d) states that if the
Commissioner of Food and Drugs (the Commissioner), decides to initiate
a proceeding to make a device, ``a banned device,'' a notice of
proposed rulemaking will be published in the Federal Register and this
document will contain the finding that the device presents a
substantial deception or an unreasonable and substantial risk of
illness or injury. The document will also contain the reasons why the
proceeding was initiated, an evaluation of data and information
obtained under other provisions of the act, any consultations with the
panel, and a determination as to whether the device could be corrected
by labeling, change of labeling, change of advertising, and if that
labeling or change of advertising has been made. Under Sec. 895.21(d),
any interested person may request an informal hearing and submit
written comments. Under Sec. 895.22, a manufacturer, distributor, or
importer of a device may be required to submit to FDA all relevant and
available data and information to enable the Commissioner to determine
whether the device presents substantial deception, unreasonable and
substantial risk of illness or injury, or unreasonable, direct, and
substantial danger to the health of individuals.
During the past several years, there has been an average of less
than one new administrative detention action per year. Each
administrative detention will have varying amounts of data and
information that must be maintained. FDA's estimate of the burden under
the administrative detention provision is based on FDA's discussion
with one of three firms whose devices had been detained.
In the Federal Register of October 16, 2009 (74 FR 53257), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(g) 1 1 1 25 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
895.21(d) and 895.22(a) 26 1 26 16 416
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 441
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(k) 1 1 1 20 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 461
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-795 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
