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74926 Federal Register / Vol. 71, No.

239 / Wednesday, December 13, 2006 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued


No. of No. of Responses Total Annual Hours per
21 CFR Section Total Hours
Respondents per Respondent Responses Response

Total Reporting Burden Hours 3,678.50


1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Applications submitted under § 601.2.
3 Supplements submitted under § 601.12(f)(1) and (f)(2).
4 Annual reports submitted under § 601.12(f)(3).

Dated: December 6, 2006. DATES: Fax written comments on the surveillance (PS) of any device that
Jeffrey Shuren, collection of information by January 12, meets the criteria set forth in the statute.
Assistant Commissioner for Policy. 2007. The PS regulation establishes
[FR Doc. E6–21132 Filed 12–12–06; 8:45 am] procedures that FDA uses to approve
ADDRESSES: To ensure that comments on
and disapprove PS plans. The regulation
BILLING CODE 4160–01–S the information collection are received,
provides specific, clear, and flexible
OMB recommends that written
instructions to manufacturers so they
comments be faxed to the Office of
DEPARTMENT OF HEALTH AND know what information is required in a
Information and Regulatory Affairs,
HUMAN SERVICES PS plan submission. FDA reviews
OMB, Attn: FDA Desk Officer, FAX:
submissions in accordance with part
Food and Drug Administration 202–395–6974.
822 (21 CFR part 822) in §§ 822.15 to
FOR FURTHER INFORMATION CONTACT: 822.18 of the regulation, which describe
[Docket No. 2006N–0382] Denver Presley, Jr., Office of the Chief the grounds for approving or
Information Officer (HFA–250), Food disapproving a PS plan. If this
Agency Information Collection
and Drug Administration, 5600 Fishers information is not collected, FDA would
Activities; Submission for Office of
Lane, Rockville, MD 20857, 301–827– not be able to ensure that the PS will
Management and Budget Review;
1472. result in the collection of useful data
Comment Request; Postmarket
that could reveal unforeseen adverse
Surveillance SUPPLEMENTARY INFORMATION: In events or other information necessary to
AGENCY: Food and Drug Administration, compliance with 44 U.S.C. 3507, FDA protect the public health.
HHS. has submitted the following proposed Respondents to this collection of
collection of information to OMB for information are those manufacturers
ACTION: Notice.
review and clearance. who require PS of their products.
SUMMARY: The Food and Drug Postmarket Surveillance—21 CFR Part In the Federal Register of October 2,
Administration (FDA) is announcing 822 (OMB No. 0910–0449)—Extension 2006 (71 FR 57973), FDA published a
that a proposed collection of 60-day notice requesting public
information has been submitted to the Section 522(a) of the Federal Food, comment on the information collection
Office of Management and Budget Drug and Cosmetic Act (the act) (21 provisions. No comments were received.
(OMB) for review and clearance under U.S.C. 360(l)) authorizes FDA to require FDA estimates the burden of this
the Paperwork Reduction Act of 1995. manufacturers to conduct postmarket collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Respondents per Response Responses Response

822.9, 822.10 5 1 5 120 600

822.21 3 1 3 40 120

822.26 1 1 1 8 8

822.27 1 1 1 40 40

822.28 1 1 1 40 40

822.29 1 1 1 120 120

822.30 1 1 1 40 40

822.34 1 1 1 20 20

822.38 10 2 20 120 2,400


hsrobinson on PROD1PC76 with NOTICES

Total 3,338
1There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices 74927

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Recordkeepers per Recordkeeping Records Record

822.31 10 1 10 20 200

822.32 30 1 30 10 300

Total 500
1There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that, based on current DEPARTMENT OF HEALTH AND registration fee payable to SoCRA.To
staffing and resources and experience HUMAN SERVICES register via the Internet go to http://
with five actual PS actions over the past www.socra.org/html/
3 years, five PS actions will be issued Food and Drug Administration FDAlConference.htm (FDA has
for generic devices, comprised of verified the Web site address, but is not
approximately five manufacturers. Each Industry Exchange Workshop on Food responsible for subsequent changes to
manufacturer will be required to submit and Drug Administration Clinical Trial the Web site after this document
a PS plan (§§ 822.9 and 822.10) and Requirements; Public Workshop publishes in the Federal Register).
interim and final reports on the progress AGENCY: Food and Drug Administration, The registrar will also accept payment
of the PS (§ 822.38). FDA anticipates HHS. by major credit cards. For more
that, on a case-by-case basis, requests for ACTION: Notice of public workshop. information on the meeting, or for
additional information may be made questions on registration, contact 800–
from a manufacturer. FDA expects that The Food and Drug Administration SoCRA92 (800–762–7292), or 215–822–
a small number of respondents will (FDA) Los Angeles District, in 8644, or via e-mail: socramail@aol.com.
propose changes to their PS plans cooperation with the Society of Clinical Attendees are responsible for their own
(§ 822.21), request a waiver of a specific Research Associates (SoCRA), is accommodations. To make reservations
requirement of this regulation announcing a workshop on FDA clinical at the Wyndham San Diego at Emerald
(§ 822.29), or request exemption from trial statutory and regulatory Plaza at the reduced conference rate,
the requirement to conduct PS of their requirements. This 2-day workshop for contact the hotel (see Location) before
device (§ 822.30). FDA’s experience has the clinical research community targets January 7, 2007. The registration fee will
shown that a few respondents will go sponsors, monitors, clinical be used to offset the expenses of hosting
out of business (§ 822.26) or cease investigators, institutional review the conference, including meals,
marketing the device subject to PS boards, and those who interact with refreshments, meeting rooms, and
(§ 822.28) each year. In addition, them for the purpose of conducting materials.
manufacturers must certify transfer of FDA-regulated clinical research. The Space is limited, therefore interested
records when ownership changes workshop will include both industry parties are encouraged to register early.
(§ 822.34). and FDA perspectives on proper Limited onsite registration may be
conduct of clinical trials regulated by available. Please arrive early to ensure
FDA expects that at least some of the FDA.
manufacturers will be able to satisfy the prompt registration. If you need special
Date and Time: The public workshop accommodations due to a disability,
PS requirement using information or is scheduled for Wednesday, February
data they already have. For purposes of please contact Marshalette Edwards (see
7, 2007, from 8:30 a.m. to 5 p.m. and Contact) at least 7 days in advance of
calculating burden, however, FDA has Thursday, February 8, 2007, from 8:30
assumed that each PS order can only be the workshop.
a.m. to 4:30 p.m.
satisfied by a 3-year clinically-based PS Location: The public workshop will SUPPLEMENTARY INFORMATION: The
plan, using three investigators. These be held at the Wyndham San Diego at workshop on FDA clinical trials
estimates are based on FDA’s knowledge Emerald Plaza, 400 West Broadway, San statutory and regulatory requirements
and experience with limited Diego, CA 92101, 619–239–4500, FAX: helps fulfill the Department of Health
implementation of section 522 under 619–239–3274. and Human Services’ and FDA’s
the Safe Medical Device Act of 1990. Contact: Marshalette Edwards, Food important mission to protect the public
Therefore, FDA would expect that the and Drug Administration, 1431 Harbor health by educating researchers on
recordkeeping requirements would Bay Parkwy., Alameda, CA 94502, 510– proper conduct of clinical trials. Topics
apply to a maximum of 10 337–6794, FAX: 510–337–6703 e-mail: for discussion include the following: (1)
manufacturers (3 to 4 added each year) MO.Edwards@fda.hhs.gov. FDA regulation of the conduct of
and 30 investigators (3 per PS plan). Registration: Send registration clinical research; (2) medical device,
After 3 years, FDA would expect these information (including name, title, firm drug, biological product and food
numbers to remain level as the PS plans name, address, telephone, and fax aspects of clinical research; (3)
conducted under the earliest orders number) and the registration fee of $575 investigator initiated research; (4) pre-
reach completion and new orders are (member), $650 (nonmember), $525 investigational new drug application
issued. (Government employee nonmember) or meetings and the FDA meeting process;
hsrobinson on PROD1PC76 with NOTICES

Dated: December 7, 2006. $450 (Government employee member) (5) informed consent requirements; (6)
to SoCRA , P.O. Box 101, Furlong, PA ethics in subject enrollment; (7) FDA
Jeffrey Shuren,
18925. The registration fee for regulation of institutional review
Assistant Commissioner for Policy. nonmembers includes a 1-year boards; (8) electronic records
[FR Doc. E6–21167 Filed 12–12–06; 8:45 am] membership). The registration fee for requirements; (9) adverse event
BILLING CODE 4160–01–S FDA employees is waived. Make the reporting; (10) how FDA conducts

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