81 FR 62142 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 174 (September 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 174 (September 8, 2016)
| Page Range | 62142-62143 | |
| FR Document | 2016-21554 |
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)] [Notices] [Pages 62142-62143] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21554] ----------------------------------------------------------------------- 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 [email protected]. 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, [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. 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
![62142 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
docket number, found in brackets in the from consumer representatives and types of molecules, consideration
heading of this document, into the others. ICH is concerned with should be given on a case-by-case basis
‘‘Search’’ box and follow the prompts harmonization of technical as to whether the sensitivity of the
and/or go to the Division of Dockets requirements for the registration of measurement method is appropriate
Management, 5630 Fishers Lane, Rm. pharmaceutical products for human use with the small sample volumes
1061, Rockville, MD 20852. among regulators around the world. The available.
Submit written requests for single six founding members of the ICH are the This draft guidance is being issued
copies of this guidance to the Division European Commission; the European consistent with FDA’s good guidance
of Drug Information, Center for Drug Federation of Pharmaceutical Industries practices regulation (21 CFR 10.115).
Evaluation and Research (CDER), Food Associations; the Japanese Ministry of The draft guidance, when finalized, will
and Drug Administration, 10001 New Health, Labour, and Welfare; the represent the current thinking of FDA
Hampshire Ave., Hillandale Building, Japanese Pharmaceutical Manufacturers on ICH ‘‘S3A Guidance: Note for
4th Floor, Silver Spring, MD 20993– Association; CDER and CBER, FDA; and Guidance on Toxicokinetics: The
0002; or the Office of Communication, the Pharmaceutical Research and Assessment of Systemic Exposure in
Outreach, and Development, Center for Manufacturers of America. The Toxicity Studies—Questions and
Biologics Evaluation and Research Standing Members of the ICH Answers.’’ It does not establish any
(CBER), Food and Drug Administration, Association include Health Canada and rights for any person and is not binding
10903 New Hampshire Ave., Bldg. 71, Swissmedic. Any party eligible as a on FDA or the public. You can use an
Rm. 3128, Silver Spring, MD 20993– Member in accordance with the ICH alternative approach if it satisfies the
0002. Send one self-addressed adhesive Articles of Association can apply for requirements of the applicable statutes
label to assist that office in processing membership in writing to the ICH and regulations.
your requests. The guidance may also be Secretariat. The ICH Secretariat, which
coordinates the preparation of II. Electronic Access
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See documentation, operates as an Persons with access to the Internet
the SUPPLEMENTARY INFORMATION section international nonprofit organization and may obtain the document at http://
for electronic access to the guidance is funded by the Members of the ICH www.regulations.gov, http://
document. Association. www.fda.gov/Drugs/Guidance
The ICH Assembly is the overarching ComplianceRegulatoryInformation/
FOR FURTHER INFORMATION CONTACT: body of the Association and includes
Regarding the guidance: Aisar Guidances/default.htm, or http://
representatives from each of the ICH www.fda.gov/BiologicsBloodVaccines/
Atrakchi, Center for Drug Evaluation members and observers. In May 2016,
and Research, Food and Drug GuidanceComplianceRegulatory
the ICH Assembly endorsed the draft Information/Guidances/default.htm.
Administration, Bldg. 22, Rm. 4118, guidance entitled ‘‘ICH S3A Guidance:
Silver Spring, MD 20993–0002, 301– Dated: September 1, 2016.
Note for Guidance on Toxicokinetics:
796–1036; or Anne Pilaro, Center for The Assessment of Systemic Exposure Leslie Kux,
Biologics Evaluation and Research, in Toxicity Studies—Questions and Associate Commissioner for Policy.
Food and Drug Administration, 10903 Answers’’ and agreed that the guidance [FR Doc. 2016–21552 Filed 9–7–16; 8:45 am]
New Hampshire Ave., Bldg. 71, Rm. should be made available for public BILLING CODE 4164–01–P
4025, Silver Spring, MD 20993–0002, comment. The draft guidance is the
240–402–8341. product of the Safety Expert Working
Regarding the ICH: Amanda Roache, Group of the ICH. Comments about this DEPARTMENT OF HEALTH AND
Center for Drug Evaluation and draft will be considered by FDA and the HUMAN SERVICES
Research, Food and Drug Safety Expert Working Group.
Administration, 10903 New Hampshire The draft Q&A guidance provides Food and Drug Administration
Ave., Bldg. 51, Rm. 1128, Silver Spring, additional information to facilitate [Docket No. FDA–2013–N–0557]
MD 20993–0002, 301–796–4548. interpretation of the S3A guidance. The
SUPPLEMENTARY INFORMATION: S3A guidance has been successfully Agency Information Collection
implemented since 1994, and in recent Activities; Submission for Office of
I. Background
years, analytical method sensitivity has Management and Budget Review;
In recent years, many important improved, allowing microsampling Comment Request; Postmarket
initiatives have been undertaken by techniques to be used in toxicokinetic Surveillance
regulatory authorities and industry assessment. This Q&A guidance focuses
associations to promote international on points to consider before AGENCY: Food and Drug Administration,
harmonization of regulatory incorporating the microsampling HHS.
requirements. FDA has participated in method in toxicokinetic studies, ACTION: Notice.
many meetings designed to enhance acknowledges the benefits (and some
harmonization and is committed to limitations) of the use of microsampling SUMMARY: The Food and Drug
seeking scientifically based harmonized for assessing toxicokinetics in main Administration (FDA) is announcing
technical procedures for pharmaceutical study animals, and acknowledges the that a proposed collection of
development. One of the goals of overall important contribution of information has been submitted to the
harmonization is to identify and then microsampling to the 3Rs benefits Office of Management and Budget
reduce differences in technical (Replacement, Reduction, and (OMB) for review and clearance under
mstockstill on DSK3G9T082PROD with NOTICES
requirements for drug development Refinement), by reducing or eliminating the Paperwork Reduction Act of 1995.
among regulatory Agencies. the need for toxicokinetic satellite DATES: Fax written comments on the
ICH was organized to provide an animals. collection of information by October 11,
opportunity for harmonization The draft Q&A guidance is intended 2016.
initiatives to be developed with input to apply to the majority of ADDRESSES: To ensure that comments on
from both regulatory and industry pharmaceuticals and the information collection are received,
representatives. FDA also seeks input biopharmaceuticals; however, for all OMB recommends that written
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![Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62143
comments be faxed to the Office of collection of information to OMB for accordance with part 822 (21 CFR part
Information and Regulatory Affairs, review and clearance. 822) in §§ 822.15 through 822.19 of the
OMB, Attn: FDA Desk Officer, FAX: regulation, which describe the grounds
202–395–7285, or emailed to oira_ Postmarket Surveillance—21 CFR Part for approving or disapproving a PS plan.
submission@omb.eop.gov. All 822—OMB Control Number 0910– In addition, the PS regulation provides
comments should be identified with the 0449—Extension instructions to manufacturers to submit
OMB control number 0910–0449. Also Section 522 of the Federal Food, Drug, interim and final reports in accordance
include the FDA docket number found and Cosmetic Act (21 U.S.C. 360l) with § 822.38. Respondents to this
in brackets in the heading of this authorizes FDA to require a collection of information are those
document. manufacturer to conduct postmarket manufacturers who require postmarket
FOR FURTHER INFORMATION CONTACT: FDA surveillance (PS) of any device that surveillance of their products.
PRA Staff, Office of Operations, Food meets the criteria set forth in the statute. In the Federal Register of April 28,
and Drug Administration, Three White The PS regulation establishes 2016 (81 FR 25409), FDA published a
Flint North, 10A63, 11601 Landsdown procedures that FDA uses to approve 60-day notice requesting public
St., North Bethesda, MD 20852, and disapprove PS plans. The regulation comment on the proposed collection of
PRAStaff@fda.hhs.gov. provides instructions to manufacturers information. No comments were
SUPPLEMENTARY INFORMATION: In so they know what information is received.
compliance with 44 U.S.C. 3507, FDA required in a PS plan submission. FDA FDA estimates the burden of this
has submitted the following proposed reviews PS plan submissions in collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Postmarket surveillance submission (§§ 822.9 and 822.10) 131 1 131 120 15,720
Changes to PS plan after approval (§ 822.21) .................... 15 1 15 40 600
Changes to PS plan for a device that is no longer mar-
keted (§ 822.28) ................................................................ 80 1 80 8 640
Waiver (§ 822.29) ................................................................. 1 1 1 40 40
Exemption request (§ 822.30) .............................................. 16 1 16 40 640
Periodic reports (§ 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 Sections 822.26, 822.27, and 822.34 do that necessary to identify the
Estimate: The burden captured in table not constitute information collection respondent, the date, the respondents
1 of this document is based on the data subject to review under the PRA address, and the nature of the
from FDA’s internal tracking system. because it entails no burden other than instrument (See 5 CFR 1320.3(h)(1)).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Manufacturer records (§ 822.31) .......................................... 131 1 131 20 2,620
Investigator records (§ 822.32) ............................................ 393 1 393 5 1,965
Total .............................................................................. ........................ ........................ ........................ ........................ 4,585
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Recordkeeping Burden Dated: September 1, 2016. DEPARTMENT OF HEALTH AND
Estimate: FDA expects that at least some Leslie Kux, HUMAN SERVICES
of the manufacturers will be able to Associate Commissioner for Policy.
satisfy the PS requirement using Food and Drug Administration
[FR Doc. 2016–21554 Filed 9–7–16; 8:45 am]
information or data they already have. BILLING CODE 4160–01–P
For purposes of calculating burden, [Docket No. FDA–2016–P–1037]
however, FDA has assumed that each PS
mstockstill on DSK3G9T082PROD with NOTICES
order can only be satisfied by a 3-year Determination That PREVACID IV
clinically based surveillance plan, using (Lansoprazole) Intravenous Injection,
three investigators. These estimates are 30 Milligrams/Vial, Was Not Withdrawn
From Sale for Reasons of Safety or
based on FDA’s knowledge and
Effectiveness
experience with postmarket
surveillance. AGENCY: Food and Drug Administration,
HHS.
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Document Created: 2018-02-09 13:12:25
Document Modified: 2018-02-09 13:12:25
| 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 October 11, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 62142 |
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