Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization, 7276-7277 [2010-3027]

Download as PDF 7276 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices concluding that foods containing the expression products can be safely consumed; • Information comparing the composition or characteristics of the bioengineered food to that of food derived from the parental variety or other commonly consumed varieties of the same crop with special emphasis on important nutrients, and toxicants that occur naturally in the food; • A discussion of the available information that addresses whether the potential for the food derived from a bioengineered plant to induce an allergic response has been altered by the genetic modification; and • Any other information relevant to the safety and nutritional assessment of the bioengineered food. In 2001, FDA contacted 5 firms that had made 1 or more biotechnology consultation submissions under the 1996 procedures. FDA asked each of these firms for an estimate of the hourly burden to prepare a submission under the voluntary biotechnology consultation process. Three of these firms subsequently provided the requested information. Based on this information, FDA estimated that the average time to prepare a submission for final consultation under the 1996 procedures is 150 hours (69 FR 68379 at 68381). The availability of the form, and the opportunity to provide the information in electronic format, could reduce this estimate. However, as a conservative approach for the purpose of this analysis, FDA is assuming that the availability of the form and the opportunity to submit the information in electronic format will have no effect on the average time to prepare a submission for final consultation under the 1996 procedures. Dated: February 4, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–3028 Filed 2–17–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration WReier-Aviles on DSKGBLS3C1PROD with NOTICES [Docket No. FDA–2010–N–0070] Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Nov<24>2008 16:37 Feb 17, 2010 Jkt 220001 SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the 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 requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. DATES: Submit written or electronic comments on the collection of information by April 19, 2010. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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. 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) 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 estimates the burden of this collection of information as follows: E:\FR\FM\18FEN1.SGM 18FEN1 7277 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response 801.150(e) 1 There 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 Annual Frequency per Recordkeeping 90 20 Hours per Record 1,800 Total Operating & Maintenance Costs Total Hours 0.5 900 $55,800 are no capital costs associated with this collection of information. 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 four 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 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. WReier-Aviles on DSKGBLS3C1PROD with NOTICES Total Annual Records Dated: February 4, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–3027 Filed 2–17–10; 8:45 am] BILLING CODE 4160–01–S VerDate Nov<24>2008 16:37 Feb 17, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0055] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the 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 the reporting requirements for the information collection activity ‘‘Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine.’’ DATES: Submit written or electronic comments on the collection of information by April 19, 2010. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3793. 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7276-7277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 
requirements relating to shipment of nonsterile devices that are to be 
sterilized elsewhere or are shipped to other establishments for further 
processing, labeling, or repacking.

DATES:  Submit written or electronic comments on the collection of 
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 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.

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 estimates the burden of this collection of information as 
follows:

[[Page 7277]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR 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      Hours per                             Total Operating &
           21 CFR Section               Recordkeepers    per Recordkeeping      Records           Record           Total Hours        Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2)                                       90                  20            1,800              0.5                   900               $55,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    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 four 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 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.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3027 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
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