81 FR 21354 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 69 (April 11, 2016)

Page Range		21354-21355
FR Document		2016-08161

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.

Federal Register, Volume 81 Issue 69 (Monday, April 11, 2016)

[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21354-21355]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08161]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0306]


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.

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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 May 11, 
2016.

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 emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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--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 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

[[Page 21355]]

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.
    In the Federal Register of October 19, 2015 (80 FR 63232), 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\
----------------------------------------------------------------------------------------------------------------
                                                     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
         21 CFR Section              Number of      records per    Total  annual    burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
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: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08161 Filed 4-8-16; 8:45 am]
 BILLING CODE 4164-01-P

21354 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices

ANNUAL BURDEN ESTIMATES
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response

Participant Entry Survey ...................................................... 504,279 168,093 1 .25 42,023
Participant Exit Survey ......................................................... 551,847 183,949 1 .50 91,975
Performance reporting system data form—grantees .......... 951 317 2 30 19,020
Performance reporting system data form—subawardees ... 5,883 1,961 2 14 54,908

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Administrative Detention and Banned
Hours: 207,926 HUMAN SERVICES Medical Devices—21 CFR 800.55(g)(1)
In compliance with the requirements and (g)(2), 800.55(k), 895.21(d), and
of Section 3506(c)(2)(A) of the Food and Drug Administration 895.22; OMB Control Number 0910–
0114—Extension
Paperwork Reduction Act of 1995, the
Administration for Children and [Docket No. FDA–2012–N–0306] FDA has the statutory authority under
Families is soliciting public comment section 304(g) of the Federal Food, Drug,
on the specific aspects of the Agency Information Collection and Cosmetic Act (the FD&C Act) (21
information collection described above. Activities; Submission for Office of U.S.C. 334(g)) to detain during
Copies of the proposed collection of Management and Budget Review; established inspections devices that are
information can be obtained and Comment Request; Administrative believed to be adulterated or
Detention and Banned Medical Devices misbranded. Section 800.55 (21 CFR
comments may be forwarded by writing
800.55), on administrative detention,
to the Administration for Children and includes among other things, certain
AGENCY: Food and Drug Administration,
Families, Office of Planning, Research reporting requirements and
HHS.
and Evaluation, 330 C Street SW., recordkeeping requirements. Under
Washington, DC 20201, Attn: OPRE ACTION: Notice. § 800.55(g), an applicant of a detention
Reports Clearance Officer. Email order must show documentation of
address: OPREinfocollection@ SUMMARY: The Food and Drug ownership if devices are detained at a
acf.hhs.gov. All requests should be Administration (FDA) is announcing place other than that of the appellant.
identified by the title of the information that a proposed collection of Under § 800.55(k), the owner or other
collection. information has been submitted to the responsible person must supply records
The Department specifically requests Office of Management and Budget about how the devices may have
comments on (a) whether the proposed (OMB) for review and clearance under become adulterated or misbranded, in
collection of information is necessary the Paperwork Reduction Act of 1995. addition to records of distribution of the
for the proper performance of the detained devices. These recordkeeping
DATES: Fax written comments on the requirements for administrative
functions of the agency, including collection of information by May 11, detentions permit FDA to trace devices
whether the information shall have 2016. for which the detention period expired
practical utility; (b) the accuracy of the before a seizure is accomplished or
agency’s estimate of the burden of the ADDRESSES: To ensure that comments on
injunctive relief is obtained.
proposed collection of information; (c) the information collection are received,
FDA also has the statutory authority
the quality, utility, and clarity of the OMB recommends that written under section 516 of the FD&C Act (21
information to be collected; and (d) comments be faxed to the Office of U.S.C. 360f) to ban devices that present
ways to minimize the burden of the Information and Regulatory Affairs, substantial deception or an
collection of information on OMB, Attn: FDA Desk Officer, FAX: unreasonable and substantial risk of
respondents, including through the use 202–395–7285, or emailed to oira_ illness or injury. Section 895.21 (21 CFR
of automated collection techniques or submission@omb.eop.gov. All 895.21), on banned devices, contains
other forms of information technology. comments should be identified with the certain reporting requirements. Section
Consideration will be given to OMB control number 0910–0114. Also 895.21(d) describes the procedures for
comments and suggestions submitted include the FDA docket number found banning a device when the
within 60 days of this publication. in brackets in the heading of this Commissioner of Food and Drugs (the
document. Commissioner) decides to initiate such
Robert Sargis a proceeding. Under 21 CFR 895.22, a
Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: FDA manufacturer, distributor, or importer of
[FR Doc. 2016–08201 Filed 4–8–16; 8:45 am] PRA Staff, Office of Operations, Food a device may be required to submit to
BILLING CODE 4184–37–P
and Drug Administration, 8455 FDA all relevant and available data and
Colesville Rd., COLE–14526, Silver information to enable the Commissioner
Spring, MD 20993–0002, PRAStaff@ to determine whether the device
mstockstill on DSK4VPTVN1PROD with NOTICES

fda.hhs.gov. presents substantial deception,
unreasonable and substantial risk of
SUPPLEMENTARY INFORMATION: In illness or injury, or unreasonable, direct,
compliance with 44 U.S.C. 3507, FDA and substantial danger to the health of
has submitted the following proposed individuals.
collection of information to OMB for During the past several years, there
review and clearance. has been an average of less than one
new administrative detention action per

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Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21355

year. Each administrative detention will based on FDA’s discussion with one of comment on the proposed collection of
have varying amounts of data and the firms whose devices had been information. No comments were
information that must be maintained. detained. received.
FDA’s estimate of the burden under the In the Federal Register of October 19,
FDA estimates the burden of this
administrative detention provision is 2015 (80 FR 63232), FDA published a
collection of information as follows:
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR Section responses per 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 Total Average
Number of
21 CFR Section records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping

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: April 5, 2016. ACTION: Notice. each information collection are shown
Leslie Kux, in table 1. Copies of the supporting
Associate Commissioner for Policy. SUMMARY: The Food and Drug statements for the information
Administration (FDA) is publishing a collections are available on the Internet
[FR Doc. 2016–08161 Filed 4–8–16; 8:45 am]
list of information collections that have
BILLING CODE 4164–01–P at http://www.reginfo.gov/public/do/
been approved by the Office of
PRAMain. An Agency may not conduct
Management and Budget (OMB) under
or sponsor, and a person is not required
DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995.
to respond to, a collection of
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: FDA
information unless it displays a
PRA Staff, Office of Operations, Food
currently valid OMB control number.
Food and Drug Administration and Drug Administration, 8455
[Docket Nos. FDA–2012–N–0564, FDA–
Colesville Rd., COLE–14526, Silver
2015–N–0797, FDA–2012–N–0021, FDA– Spring, MD 20993–0002, PRAStaff@
2012–N–0280, FDA–2007–D–0372, FDA– fda.hhs.gov.
2014–D–0044] SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
Agency Information Collection
collections recently approved by OMB
Activities; Announcement of Office of
under section 3507 of the Paperwork
Management and Budget Approvals
Reduction Act of 1995 (44 U.S.C. 3507).
AGENCY: Food and Drug Administration, The OMB control number and
HHS. expiration date of OMB approval for

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires

Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act ....................................................................................................................................................... 0910–0642 2/28/2019
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ...................................... 0910–0752 2/28/2019
Substances Generally Recognized as Safe: Notification Procedure ...................................................................... 0910–0342 3/31/2019
Financial Disclosure by Clinical Investigators ......................................................................................................... 0910–0396 3/31/2019
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act .......................................................................................... 0910–0635 3/31/2019
mstockstill on DSK4VPTVN1PROD with NOTICES

Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Proce-
dures, Conduct of Audits, and Records ............................................................................................................... 0910–0811 3/31/2019

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Document Created: 2016-04-09 00:11:34
Document Modified: 2016-04-09 00:11:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 11, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 21354

81 FR 21354 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 69 (April 11, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration