Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices, 21354-21355 [2016-08161]

Download as PDF 21354 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Participant Entry Survey ...................................................... Participant Exit Survey ......................................................... Performance reporting system data form—grantees .......... Performance reporting system data form—subawardees ... Estimated Total Annual Burden Hours: 207,926 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 Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ 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. Robert Sargis Reports Clearance Officer. 504,279 551,847 951 5,883 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: BILLING CODE 4184–37–P 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. SUMMARY: Fax written comments on the collection of information by May 11, 2016. DATES: 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 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. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ 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: VerDate Sep<11>2014 18:37 Apr 08, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Number of responses per respondent 168,093 183,949 317 1,961 FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–08201 Filed 4–8–16; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES Annual number of respondents 1 1 2 2 Average burden hours per response .25 .50 30 14 Annual burden hours 42,023 91,975 19,020 54,908 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 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 E:\FR\FM\11APN1.SGM 11APN1 21355 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 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 responses per respondent Number of respondents 21 CFR Section 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 Number of recordkeepers 21 CFR Section 800.55(k) .............................................................................. 1 There 1 Total annual records 1 Average burden per recordkeeping 1 20 Total hours 20 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. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2012–N–0564, FDA– 2015–N–0797, FDA–2012–N–0021, FDA– 2012–N–0280, FDA–2007–D–0372, FDA– 2014–D–0044] each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for SUPPLEMENTARY INFORMATION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Food and Drug Administration, HHS. Notice. SUMMARY: [FR Doc. 2016–08161 Filed 4–8–16; 8:45 am] AGENCY: Number of records per recordkeeper TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. mstockstill on DSK4VPTVN1PROD with NOTICES Title of collection Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act ....................................................................................................................................................... Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ...................................... Substances Generally Recognized as Safe: Notification Procedure ...................................................................... Financial Disclosure by Clinical Investigators ......................................................................................................... Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act .......................................................................................... Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records ............................................................................................................... VerDate Sep<11>2014 18:37 Apr 08, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11APN1.SGM 11APN1 Date approval expires 0910–0642 0910–0752 0910–0342 0910–0396 2/28/2019 2/28/2019 3/31/2019 3/31/2019 0910–0635 3/31/2019 0910–0811 3/31/2019

Agencies

[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21354-21355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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 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: 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: 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

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