Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly “Reprocessed Single-Use Device Labeling”), 67873-67874 [E8-27178]

Download as PDF 67873 Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices 2011; and (4) identifies technical resources for use by State courts during the course of the program. This Program Instruction contains information collection requirements pursuant to receiving a grant award that are found in Public Law 103–66, as amended by Public Law 105–89, Public Law 107– 133, Public Law 109–239, and Public Law 109–288. The agency will use the information received to ensure compliance with the statute and provide Number of respondents Instrument Application ....................................................................................................... Annual program report ..................................................................................... Estimated Total Annual Burden Hours: 3,952. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: November 12, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–27234 Filed 11–14–08; 8:45 am] jlentini on PROD1PC65 with NOTICES BILLING CODE 4184–01–P VerDate Aug<31>2005 18:18 Nov 14, 2008 Jkt 217001 Food and Drug Administration [Docket No. FDA–2008–N–0571] Food and Drug Administration, HHS. 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 reprocessed single-use device labeling. DATES: Submit written or electronic comments on the collection of information by January 16, 2009. ADDRESSES: Submit electronic comments on the collection of information to: http:// 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 00039 Fmt 4703 Sfmt 4703 1 1 Average burden hours per response Total burden hours 40 36 2,080 1,872 FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 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: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ‘‘Reprocessed Single-Use Device Labeling’’) ACTION: Number of responses per respondent 52 52 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: training and technical assistance to the grantees. Respondents: State Courts. Annual Burden Estimates. E:\FR\FM\17NON1.SGM 17NON1 67874 Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ‘‘Reprocessed SingleUse Device Labeling’’) (Federal Food, Drug, and Cosmetic Act, Section 502(u)) (OMB Control Number 0910–0577)— Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352), among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. Section 301 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) amended section 502 of the act to add section 502(u) to require devices (both new and reprocessed) to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. Thus, the name for this information collection activity has been changed to more accurately describe the information collection content. Section 2(c) of The Medical Device User Fee Stabilization Act of 2005 (Public Law 109–43) amends section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Under the amended provision, if the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. If the original SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may identify itself using a detachable label that is intended to be affixed to the patient record. The requirements of section 502(u) of the act impose a minimal burden on industry. This section of the act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 10 establishments that distribute approximately 1,000 reprocessed SUDs. Each response is anticipated to take 0.1 hours resulting in a total burden to industry of 100 hours. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Section of the Act 502(u) No. of Responses per Respondent 10 1 There Total Annual Responses 100 1,000 Dated: November 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–27178 Filed 11–14–08; 8:45 am] BILLING CODE 4160–01–S SOMATULINE DEPOT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0111] Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT jlentini on PROD1PC65 with NOTICES Food and Drug Administration, HHS. ACTION: Total Hours .1 100 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. AGENCY: Hours Per Response Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VerDate Aug<31>2005 18:18 Nov 14, 2008 Jkt 217001 Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product SOMATULINE DEPOT (lanreotide). SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67873-67874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27178]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0571]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry and Food and Drug Administration 
Staff; Compliance With the Medical Device User Fee and Modernization 
Act of 2002, as Amended: Prominent and Conspicuous Mark of 
Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-Use 
Device Labeling'')

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 reprocessed single-use device 
labeling.

DATES: Submit written or electronic comments on the collection of 
information by January 16, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

[[Page 67874]]

Compliance With Section 301 of the Medical Device User Fee and 
Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark 
of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-
Use Device Labeling'') (Federal Food, Drug, and Cosmetic Act, Section 
502(u)) (OMB Control Number 0910-0577)--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 352), among other things, establishes requirements that the 
label or labeling of a medical device must meet so that it is not 
misbranded and subject to regulatory action. Section 301 of the Medical 
Device User Fee and Modernization Act of 2002 (Public Law 107-250) 
amended section 502 of the act to add section 502(u) to require devices 
(both new and reprocessed) to bear prominently and conspicuously the 
name of the manufacturer, a generally recognized abbreviation of such 
name, or a unique and generally recognized symbol identifying the 
manufacturer. Thus, the name for this information collection activity 
has been changed to more accurately describe the information collection 
content.
    Section 2(c) of The Medical Device User Fee Stabilization Act of 
2005 (Public Law 109-43) amends section 502(u) of the act by limiting 
the provision to reprocessed single-use devices (SUDs) and the 
manufacturers who reprocess them. Under the amended provision, if the 
original SUD or an attachment to it prominently and conspicuously bears 
the name of the manufacturer, then the reprocessor of the SUD is 
required to identify itself by name, abbreviation, or symbol, in a 
prominent and conspicuous manner on the device or attachment to the 
device. If the original SUD does not prominently and conspicuously bear 
the name of the manufacturer, the manufacturer who reprocesses the SUD 
for reuse may identify itself using a detachable label that is intended 
to be affixed to the patient record.
    The requirements of section 502(u) of the act impose a minimal 
burden on industry. This section of the act only requires the 
manufacturer, packer, or distributor of a device to include their name 
and address on the labeling of a device. This information is readily 
available to the establishment and easily supplied. From its 
registration and premarket submission database, FDA estimates that 
there are 10 establishments that distribute approximately 1,000 
reprocessed SUDs. Each response is anticipated to take 0.1 hours 
resulting in a total burden to industry of 100 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of        No. of Responses  per      Total Annual        Hours Per
                 Section of the Act                     Respondents            Respondent            Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
502(u)                                                              10                      100              1,000                 .1                100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27178 Filed 11-14-08; 8:45 am]
BILLING CODE 4160-01-S