Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices, 65683-65685 [2018-27655]

Download as PDF 65683 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices section shall be made available for inspection and copying by FDA. Description of Respondents: Respondents include renderers, feed manufacturers, and others involved in feed and feed ingredient manufacturing and distribution. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section; activity 589.2000(e)(1)(iv); written procedures .. 1 There 320 Dated: December 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–27656 Filed 12–20–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4465] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 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 February 19, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 Total annual records 1 Average burden per recordkeeping 320 14 Total hours 4,480 are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimates on our experience with similar requirements to maintain written procedures. We base our estimate of the number of recordkeepers on inspectional data. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. AGENCY: Number of records per recordkeeper VerDate Sep<11>2014 00:00 Dec 21, 2018 Jkt 247001 considered. Electronic comments must be submitted on or before February 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 19, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Staff, 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– 2018–N–4465 for ‘‘Administrative Detention and Banned Medical Devices.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. E:\FR\FM\21DEN1.SGM 21DEN1 65684 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. 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. SUPPLEMENTARY INFORMATION: 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 895.229(a) 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 (§ 800.55(g)(1) and (g)(2)) and recordkeeping requirements (§ 800.55(k)). Under § 800.55(g), an appellant 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 year. Each administrative detention will have varying amounts of data and information that must be maintained. 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 Average burden per response Total annual responses Total hours Documentation of ownership—800.55(g) ............................ Banned devices reporting requirements—895.21(d)(8) and 895.22(a) .......................................................................... 1 1 1 25 25 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 recordkeepers amozie on DSK3GDR082PROD with NOTICES1 21 CFR section Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k) ... 1 There Number of records per recordkeeper 1 Average burden per recordkeeping Total annual records 1 1 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 00:00 Dec 21, 2018 Jkt 247001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1 20 Total hours 20 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: December 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–27655 Filed 12–20–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3552] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Cigarette Warnings AGENCY: Food and Drug Administration, HHS. ACTION: 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 January 22, 2019. 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–NEW and title ‘‘Experimental Study of Cigarette Warnings.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: amozie on DSK3GDR082PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, 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 00:00 Dec 21, 2018 Jkt 247001 Experimental Study of Cigarette Warnings OMB Control Number 0910–NEW The Tobacco Control Act (Pub. L. 111–31) amends the Federal Food, Drug, and Cosmetic Act to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act amends section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection 4(a)(1) of the FCLAA. Section 202(b) of the Tobacco Control Act further amends section 4 of the FCLAA by adding that the Secretary of Health and Human Services (Secretary), through notice and comment rulemaking, may adjust the text of any of the label requirements if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products. In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued a final rule entitled ‘‘Required Warnings for Cigarette Packages and Advertisements,’’ which specified nine images to accompany new textual warning statements for cigarettes. Although the rule was scheduled to become effective 15 months after it issued, a panel of the U.S. Court of Appeals of the District of Columbia held, on August 24, 2012, that the rule in its current form violated the First Amendment. In a letter to Congress on March 15, 2013, the Attorney General reported FDA’s intention to undertake research to support a new rulemaking consistent with the Tobacco Control Act. Various phases of research have been underway since 2013. The next phase of the research includes the study proposed here, which is an effort by FDA to collect data concerning responses to health warnings placed on cigarette packages and advertisements for cigarettes. The health risks associated with the use of cigarettes are significant and farreaching. Cigarette smoking is the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year. Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined (Ref. 1). In addition to lung cancer, heart PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 65685 disease, and chronic obstructive pulmonary disease, smoking also causes numerous other serious health conditions including several types of cancer, premature birth, low birth weight, respiratory illnesses, clogged arteries, reduced blood flow, diabetes, and vision conditions such as agerelated macular degeneration and cataracts (Ref. 2). Approximately 37.8 million U.S. adults smoke cigarettes (Ref. 3) and 8.6 million Americans have at least one serious illness caused by smoking cigarettes (Ref. 4). Results from the 2016 National Survey on Drug Use and Health demonstrate that, each day in the United States, more than 2,300 youth under age 18 smoke their first cigarette, and nearly 400 youth become daily cigarette smokers (Ref. 5). If the current trajectory of smoking rates continues, 5.6 million children alive today will die prematurely as a result of smoking (Ref. 2). Providing the public with accurate information regarding the health consequences of cigarette use is critical in achieving FDA’s mission to protect the public health. This Experimental Study of Cigarette Warnings is a voluntary online experiment. The purpose of the study is to assess whether new cigarette health warnings increase public understanding of the negative health consequences of cigarette smoking. The study will collect data from various groups of consumers, including adolescent current cigarette smokers aged 13 to 17 years, adolescent non-smokers who are susceptible to initiation of cigarette smoking aged 13 to 17 years, young adult current cigarette smokers and non-smokers aged 18 to 24 years, and older adult current cigarette smokers and non-smokers aged 25 years and older. The results will inform the Agency’s efforts to implement the mandatory color graphics to accompany health warning label statements as required by section 4 of FCLAA. Study Overview: In this study, adolescent current cigarette smokers, adolescent non-smokers who are susceptible to initiation of cigarette smoking, young adult current cigarette smokers and non-smokers, and older adult current cigarette smokers and nonsmokers will be recruited from an existing internet panel of more than 1.2 million people and screened for inclusion into the study. Participants who meet the inclusion criteria will be randomized into 1 of 17 conditions. In each condition, respondents will view one cigarette warning. In the 16 treatment conditions, participants will view 1 cigarette health warning, containing a textual warning statement E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65683-65685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27655]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4465]

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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 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 February 19, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 19, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-4465 for ``Administrative Detention and Banned Medical
Devices.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 65684]]

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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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 895.229(a)

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 (Sec. 800.55(g)(1) and (g)(2)) and recordkeeping
requirements (Sec. 800.55(k)). Under Sec. [thinsp]800.55(g), an
appellant of a detention order must show documentation of ownership if
devices are detained at a place other than that of the appellant. Under
Sec. [thinsp]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 year. Each
administrative detention will have varying amounts of data and
information that must be maintained.
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
----------------------------------------------------------------------------------------------------------------
Documentation of ownership-- 1 1 1 25 25
800.55(g)......................
Banned devices reporting 26 1 26 16 416
requirements--895.21(d)(8) and
895.22(a)......................
-------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Records regarding device 1 1 1 20 20
adulteration or misbranding and
records of distribution of
detained devices--800.55(k)....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 65685]]

Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

Dated: December 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27655 Filed 12-20-18; 8:45 am]
BILLING CODE 4164-01-P

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