Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices, 63232-63234 [2015-26440]
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63232
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–0235 for ‘‘Evaluating the
Effectiveness of New Animal Drugs for
the Reduction of Pathogenic Shiga
Toxin-Producing E. coli in Cattle;
Guidance for Industry; Availability.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Joshua R. Hayes, Center for Veterinary
Medicine (HFV–133), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0585,
joshua.hayes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Fmt 4703
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
In the Federal Register of February
24, 2015 (80 FR 9731), FDA published
a notice of availability for a draft
guidance entitled ‘‘Evaluating the
Effectiveness of New Animal Drugs for
the Reduction of Pathogenic Shiga
Toxin-Producing E. coli in Cattle’’
giving interested persons until April 27,
2015, to comment on the draft guidance.
FDA received one comment on the draft
guidance. An editorial change to
improve clarity was made in finalizing
this guidance document. The guidance
announced in this notice finalizes the
guidance dated February 2015.
The guidance discusses general
considerations regarding the
development of protocols, study
conduct, animal welfare, substantial
evidence of effectiveness, experimental
parameters, nutritional content of
experimental diets, and the assessment
of drug concentrations in experimental
diets. It also discusses the studies and
analyses CVM recommends for sponsors
to substantiate the effectiveness of
pathogenic STEC reduction drugs.
Frm 00040
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Evaluating the
Effectiveness of New Animal Drugs for
the Reduction of Pathogenic Shiga
Toxin-Producing E. coli in Cattle.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of applicable statutes and regulations.
[FR Doc. 2015–26438 Filed 10–16–15; 8:45 am]
I. Background
PO 00000
II. Significance of Guidance
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0306]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Detention and Banned Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
SUMMARY:
E:\FR\FM\19OCN1.SGM
19OCN1
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
public comment in response to the
notice. This notice solicits comments on
information collection for
administrative detention and banned
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by December 18, 2015.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0306 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Administrative Detention and Banned
Medical Devices.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
63233
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Administrative Detention and Banned
Medical Devices—21 CFR 800.55(g)(1)
and (g)(2), 800.55(k), 895.21(d), and
895.22 OMB Control Number 0910–
0114—Extension
FDA has the statutory authority under
section 304(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 334(g)) to detain during
established inspections devices that are
believed to be adulterated or
misbranded. Section 800.55 (21 CFR
800.55), on administrative detention,
includes among other things, certain
reporting requirements and
recordkeeping requirements. 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 permit 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 FD&C Act (21
E:\FR\FM\19OCN1.SGM
19OCN1
63234
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
U.S.C. 360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. Section 895.21 (21 CFR
895.21), on banned devices, contains
certain reporting requirements. Section
895.21(d) describes the procedures for
banning a device when the
Commissioner of Food and Drugs (the
Commissioner) decides to initiate such
a proceeding. Under 21 CFR 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
the firms whose devices had been
detained.
FDA estimates the burden of this
collection of information as follows:
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
Total hours
800.55(g) ..............................................................................
895.21(d)(8) and 895.22(a) ..................................................
1
26
1
1
1
26
25
16
25
416
Total ..............................................................................
........................
........................
........................
........................
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
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
800.55(k) ..............................................................................
1
1
1
20
20
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Georgia Ave., Suite 400, Silver Spring,
MD 20910–3492.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–26440 Filed 10–16–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Office of Women’s Health Update on
Strategic Priorities and Initiatives for
Nurses
Food and Drug Administration,
HHS.
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: Office of Women’s
Health Update on Strategic Priorities
and Initiatives. FDA staff will provide
updates on strategic priorities,
educational outreach, and research
initiatives of interest to national
organizations for nursing professionals
and students.
DATES: The meeting will be held on
November 18, 2015, 1 p.m. to 3 p.m.
ADDRESSES: The meeting will be held at
the American Nurses Association, 8515
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
There is
no fee, but pre-registration is required.
Send registration information (including
name, title, organization name, address,
telephone, and fax number) to Deborah
Kallgren. Seating is limited to 35
participants (1 person per organization).
If you need special accommodations
due to a disability, please contact
Deborah Kallgren (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
ACTION:
Health Resources and Services
Administration
Deborah Kallgren, Office of Women’s
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–9440,
FAX: 301–847–8604, deborah.kallgren@
fda.hhs.gov.
BILLING CODE 4164–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26433 Filed 10–16–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Advisory Commission on Childhood
Vaccines; Request for Nominations for
Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill six
vacancies on the Advisory Commission
on Childhood Vaccines (ACCV). The
ACCV was established by Title XXI of
the Public Health Service Act (the Act),
as enacted by Public Law (Pub. L.) 99–
660 and as subsequently amended, and
advises the Secretary of Health and
Human Services (the Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP).
DATES: The agency will receive
nominations on or before December 18,
2015.
ADDRESSES: All nominations are to be
submitted to the Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau (HSB),
SUMMARY:
E:\FR\FM\19OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63232-63234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26440]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0306]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for
[[Page 63233]]
public comment in response to the notice. This notice solicits comments
on information collection for administrative detention and banned
medical devices.
DATES: Submit either electronic or written comments on the collection
of information by December 18, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0306 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Administrative Detention and
Banned Medical Devices.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Administrative Detention and Banned Medical Devices--21 CFR
800.55(g)(1) and (g)(2), 800.55(k), 895.21(d), and 895.22 OMB Control
Number 0910-0114--Extension
FDA has the statutory authority under section 304(g) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to
detain during established inspections devices that are believed to be
adulterated or misbranded. Section 800.55 (21 CFR 800.55), on
administrative detention, includes among other things, certain
reporting requirements and recordkeeping requirements. 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
permit 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 FD&C
Act (21
[[Page 63234]]
U.S.C. 360f) to ban devices that present substantial deception or an
unreasonable and substantial risk of illness or injury. Section 895.21
(21 CFR 895.21), on banned devices, contains certain reporting
requirements. Section 895.21(d) describes the procedures for banning a
device when the Commissioner of Food and Drugs (the Commissioner)
decides to initiate such a proceeding. Under 21 CFR 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 the firms whose devices had been detained.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
800.55(g)....................... 1 1 1 25 25
895.21(d)(8) and 895.22(a)...... 26 1 26 16 416
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(k).......................................................... 1 1 1 20 20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26440 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P
