Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance, 62142-62143 [2016-21554]

Download as PDF 62142 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 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 Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 4118, Silver Spring, MD 20993–0002, 301– 796–1036; or Anne Pilaro, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4025, Silver Spring, MD 20993–0002, 240–402–8341. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1128, Silver Spring, MD 20993–0002, 301–796–4548. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. In May 2016, the ICH Assembly endorsed the draft guidance entitled ‘‘ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies—Questions and Answers’’ and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Safety Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Safety Expert Working Group. The draft Q&A guidance provides additional information to facilitate interpretation of the S3A guidance. The S3A guidance has been successfully implemented since 1994, and in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be used in toxicokinetic assessment. This Q&A guidance focuses on points to consider before incorporating the microsampling method in toxicokinetic studies, acknowledges the benefits (and some limitations) of the use of microsampling for assessing toxicokinetics in main study animals, and acknowledges the overall important contribution of microsampling to the 3Rs benefits (Replacement, Reduction, and Refinement), by reducing or eliminating the need for toxicokinetic satellite animals. The draft Q&A guidance is intended to apply to the majority of pharmaceuticals and biopharmaceuticals; however, for all PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 types of molecules, consideration should be given on a case-by-case basis as to whether the sensitivity of the measurement method is appropriate with the small sample volumes available. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ICH ‘‘S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies—Questions and Answers.’’ 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 the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: September 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21552 Filed 9–7–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0557] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance 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. DATES: Fax written comments on the collection of information by October 11, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written SUMMARY: E:\FR\FM\08SEN1.SGM 08SEN1 62143 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 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 0910–0449. 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 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. Postmarket Surveillance—21 CFR Part 822—OMB Control Number 0910– 0449—Extension Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with § 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. In the Federal Register of April 28, 2016 (81 FR 25409), 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 respondents Activity/21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours Postmarket surveillance submission (§§ 822.9 and 822.10) Changes to PS plan after approval (§ 822.21) .................... Changes to PS plan for a device that is no longer marketed (§ 822.28) ................................................................ Waiver (§ 822.29) ................................................................. Exemption request (§ 822.30) .............................................. Periodic reports (§ 822.38) ................................................... 131 15 1 1 131 15 120 40 15,720 600 80 1 16 131 1 1 1 3 80 1 16 393 8 40 40 40 640 40 640 15,720 Total .............................................................................. ........................ ........................ ........................ ........................ 33,360 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Reporting Burden Estimate: The burden captured in table 1 of this document is based on the data from FDA’s internal tracking system. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because it entails no burden other than that necessary to identify the respondent, the date, the respondents address, and the nature of the instrument (See 5 CFR 1320.3(h)(1)). TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity/21 CFR section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Manufacturer records (§ 822.31) .......................................... Investigator records (§ 822.32) ............................................ 131 393 1 1 131 393 20 5 2,620 1,965 Total .............................................................................. ........................ ........................ ........................ ........................ 4,585 mstockstill on DSK3G9T082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Recordkeeping Burden Estimate: FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically based surveillance plan, using three investigators. These estimates are based on FDA’s knowledge and experience with postmarket surveillance. Dated: September 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21554 Filed 9–7–16; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–P–1037] Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62142-62143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0557]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance

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 October
11, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written

[[Page 62143]]

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 0910-0449. 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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.

Postmarket Surveillance--21 CFR Part 822--OMB Control Number 0910-
0449--Extension

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) authorizes FDA to require a manufacturer to conduct postmarket
surveillance (PS) of any device that meets the criteria set forth in
the statute. The PS regulation establishes procedures that FDA uses to
approve and disapprove PS plans. The regulation provides instructions
to manufacturers so they know what information is required in a PS plan
submission. FDA reviews PS plan submissions in accordance with part 822
(21 CFR part 822) in Sec. Sec. 822.15 through 822.19 of the
regulation, which describe the grounds for approving or disapproving a
PS plan. In addition, the PS regulation provides instructions to
manufacturers to submit interim and final reports in accordance with
Sec. 822.38. Respondents to this collection of information are those
manufacturers who require postmarket surveillance of their products.
In the Federal Register of April 28, 2016 (81 FR 25409), 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
Activity/21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Postmarket surveillance 131 1 131 120 15,720
submission (Sec. Sec. 822.9
and 822.10)....................
Changes to PS plan after 15 1 15 40 600
approval (Sec. 822.21).......
Changes to PS plan for a device 80 1 80 8 640
that is no longer marketed
(Sec. 822.28)................
Waiver (Sec. 822.29).......... 1 1 1 40 40
Exemption request (Sec. 16 1 16 40 640
822.30)........................
Periodic reports (Sec. 822.38) 131 3 393 40 15,720
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 33,360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Explanation of Reporting Burden Estimate: The burden captured in
table 1 of this document is based on the data from FDA's internal
tracking system. Sections 822.26, 822.27, and 822.34 do not constitute
information collection subject to review under the PRA because it
entails no burden other than that necessary to identify the respondent,
the date, the respondents address, and the nature of the instrument
(See 5 CFR 1320.3(h)(1)).

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturer records (Sec. 131 1 131 20 2,620
822.31)........................
Investigator records (Sec. 393 1 393 5 1,965
822.32)........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,585
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with postmarket surveillance.

Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21554 Filed 9-7-16; 8:45 am]
BILLING CODE 4160-01-P

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