Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization, 21631-21632 [2010-9555]

Download as PDF 21631 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices interventions for BMSM. Men will complete a 5-minute eligibility screening interview. The baseline computer-based survey will take 45 minutes. The qualitative interview will take approximately 75 minutes. The number of respondents who will accept HIV testing is estimated to be 200 (accounting for those who did not test at baseline and those who do not consent to test at follow-up). HIV counseling and rapid testing will take 45 minutes. The 3-month follow-up survey will take approximately 30 minutes; the follow-up qualitative interview will take approximately 45 minutes. There is no cost to the respondents other than their time. ESTIMATE OF ANNUALIZED BURDEN TABLE Average burden per response (in hours) Number of respondents Number of responses per respondent Screening interview .......................... ACASI survey interview ................... 750 300 1 1 5/60 45/60 63 225 Qualitative interview ......................... HIV testing & counseling .................. ACASI survey interview ................... 300 200 300 1 1 1 1.25 45/60 30/60 375 150 150 Qualitative interview ......................... HIV testing & counseling .................. 300 200 1 1 45/60 45/60 225 150 Total Burden Hours .......................... ........................ ........................ ........................ 1338 Respondents Form name BMSM respondents only ................... BMSM and other MSM respondents: Baseline. BMSM and other MSM respondents: 3 month follow-up. Dated: April 19, 2010. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–9606 Filed 4–23–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0070] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization 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 26, 2010. 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the sroberts on DSKD5P82C1PROD with NOTICES ADDRESSES: VerDate Nov<24>2008 16:56 Apr 23, 2010 Jkt 220001 OMB control number 0910–0131. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@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. Agreement for Shipment of Devices for Sterilization—21 CFR 801.150(e) (OMB Control Number 0910–0131)—Extension Under sections 501(c) and 502(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are adulterated and misbranded. FDA regulations in § 801.150(e) (21 CFR 801.150(e)) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Under § 801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following: (1) Instructions for maintaining accountability of the number of units in each shipment; (2) acknowledgment that the devices that are nonsterile are being shipped for further processing; and (3) PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Total burden (in hours) specifications for sterilization processing. This agreement allows the manufacturer to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. During routine plant inspections, FDA normally reviews agreements that must be kept for 2 years after final shipment or delivery of devices (§ 801.150(a)(2)). The respondents to this collection of information are device manufacturers and contact sterilizers. FDA’s estimate of the reporting burden is based on actual data obtained from industry over the past several years where there are approximately 90 firms subject to this requirement. It is estimated that each of these firms on the average prepares 20 written agreements each year. This estimate varies greatly, from 1 to 100, because some firms provide sterilization services on a part time basis for only one customer while others are large facilities with many customers. The average time required to prepare each written agreement is estimated to be 4 hours. This estimate varies depending on whether the agreement is the initial agreement or an annual renewal, on the format each firm elects to use, and on the length of time required to reach agreement. The estimate applies only to those portions of the written agreement that pertain to the requirements imposed by this regulation. The written agreement generally also includes contractual agreements that are a customary and usual business practice. On the average, the total annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x 4 hours). The E:\FR\FM\26APN1.SGM 26APN1 21632 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices recordkeeping requirements of § 801.150(a)(2) consist of making copies and maintaining the actual reporting requests which were required under the reporting section of this collection. To fulfill this requirement, FDA estimates it will take about 30 minutes to copy each package, for a total of 900 recordkeeping hours and includes $55,800 operating and maintenance costs. In the Federal Register of February 18, 2010 (75 FR 7276), 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 BURDEN1 No. of Respondents 21 CFR Section 801.150(e) 1 There Annual Frequency per Response 90 Total Annual Responses 20 Hours per Response 1,800 Total Hours 4 7,200 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers 801.150(a)(2) 1 There 90 Dated: April 21, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–9555 Filed 4–23–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0194] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion Pump— Premarket Notification [510(k)] Submissions; Availability Food and Drug Administration, HHS. sroberts on DSKD5P82C1PROD with NOTICES 20 Hours per Record 1,800 Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ‘‘Total Product Life Cycle: Infusion Pump—Premarket Notification [510(k)] Submissions.’’ The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion pumps. VerDate Nov<24>2008 16:56 Apr 23, 2010 DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 26, 2010. Submit written or electronic comments on the collection of information by June 25, 2010. Submit written requests for single copies of the draft guidance document entitled ‘‘Total Product Life Cycle: Infusion Pump—Premarket Notification [510(k)] Submissions’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301– 847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Alan Stevens, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2561, Silver Spring, MD 20993–0002, 301–796–6294. ADDRESSES: BILLING CODE 4160–01–S ACTION: Total Annual Records Total Hours 0.5 900 are no capital costs associated with this collection of information. Due to a clerical error, the operating and maintenance costs that appeared in a document published in the Federal Register of February 18, 2010, were incorrect. There are actually no operating and maintenance costs associated. AGENCY: Annual Frequency per Recordkeeping Jkt 220001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: I. Background FDA has seen an increase in the number and severity of infusion pump recalls. Analyses of medical device reports (MDRs) revealed device problems that appear to be a result of faulty design. Between January 1, 2005, and December 31, 2009, FDA received over 56,000 MDRs associated with the use of infusion pumps. Of these reports, approximately 1 percent were reported as deaths, 32 percent were reported as serious injuries, and 64 percent were reported as malfunctions. The most frequently reported infusion pump device problems are: Software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion, and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as ‘‘unknown.’’ Subsequent root cause analyses revealed that many of these design problems were foreseeable and, therefore, preventable. After evaluating a broad spectrum of infusion pumps across manufacturers, FDA has concluded there are numerous, systemic problems with device design, manufacturing, and adverse event reporting. The agency believes that the draft guidance provides recommendations that will help mitigate current risks and reduce future risks associated with infusion pumps. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21631-21632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9555]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0070]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Agreement for
Shipment of Devices for Sterilization

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 26,
2010.

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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0131.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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.

Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e)
(OMB Control Number 0910-0131)--Extension

Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351(c) and 352(a)), nonsterile
devices that are labeled as sterile but are in interstate transit to a
facility to be sterilized are adulterated and misbranded. FDA
regulations in Sec. 801.150(e) (21 CFR 801.150(e)) establish a control
mechanism by which firms may manufacture and label medical devices as
sterile at one establishment and ship the devices in interstate
commerce for sterilization at another establishment, a practice that
facilitates the processing of devices and is economically necessary for
some firms. Under Sec. 801.150(e)(1), manufacturers and sterilizers
may sign an agreement containing the following: (1) Instructions for
maintaining accountability of the number of units in each shipment; (2)
acknowledgment that the devices that are nonsterile are being shipped
for further processing; and (3) specifications for sterilization
processing. This agreement allows the manufacturer to ship misbranded
products to be sterilized without initiating regulatory action and
provides FDA with a means to protect consumers from use of nonsterile
products. During routine plant inspections, FDA normally reviews
agreements that must be kept for 2 years after final shipment or
delivery of devices (Sec. 801.150(a)(2)). The respondents to this
collection of information are device manufacturers and contact
sterilizers. FDA's estimate of the reporting burden is based on actual
data obtained from industry over the past several years where there are
approximately 90 firms subject to this requirement. It is estimated
that each of these firms on the average prepares 20 written agreements
each year. This estimate varies greatly, from 1 to 100, because some
firms provide sterilization services on a part time basis for only one
customer while others are large facilities with many customers. The
average time required to prepare each written agreement is estimated to
be 4 hours. This estimate varies depending on whether the agreement is
the initial agreement or an annual renewal, on the format each firm
elects to use, and on the length of time required to reach agreement.
The estimate applies only to those portions of the written agreement
that pertain to the requirements imposed by this regulation. The
written agreement generally also includes contractual agreements that
are a customary and usual business practice. On the average, the total
annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x
4 hours). The

[[Page 21632]]

recordkeeping requirements of Sec. 801.150(a)(2) consist of making
copies and maintaining the actual reporting requests which were
required under the reporting section of this collection. To fulfill
this requirement, FDA estimates it will take about 30 minutes to copy
each package, for a total of 900 recordkeeping hours and includes
$55,800 operating and maintenance costs.
In the Federal Register of February 18, 2010 (75 FR 7276), 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\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
801.150(e) 90 20 1,800 4 7,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

TABLE 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2) 90 20 1,800 0.5 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

Due to a clerical error, the operating and maintenance costs that
appeared in a document published in the Federal Register of February
18, 2010, were incorrect. There are actually no operating and
maintenance costs associated.

Dated: April 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9555 Filed 4-23-10; 8:45 am]
BILLING CODE 4160-01-S

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