Draft Guidance for Industry and FDA Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of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; Availability, 59074-59075 [05-20329]

Download as PDF 59074 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices ways people can enter data into the electronic submission system to protect the database from corruption. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents Form No. Annual Frequency per Response Total Annual Responses Hours per Response 720.1 through 720.4 (new submissions) FDA 2512 and FDA 2512a 112 12.9 1,446 720.4 and 720.6 (amendments) FDA 2512 and FDA 2512a 112 0.5 720.3 and 720.6 (notices of discontinuance) FDA 2514 112 1 720.8 (requests for confidentiality) Total Hours 0.5 723 52 0.33 17 1 4 0.1 0.4 1 1 1.5 1.5 Total 742 1There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on FDA’s experience with the Cosmetic Product Voluntary Reporting Program. The estimated annual total hours burden is 75 percent of the burden reported in 2002 due to decreased submissions. However, the number of respondents doubled, and FDA attributes this to increased interest in the program. FDA expects the number of submissions to increase accordingly in the next 3 years. Dated: October 3, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–20307 Filed 10–7–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0124] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body AGENCY: Management and Budget (OMB) under the Paperwork Reduction Act of 1995. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Food and Drug Administration Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. In the Federal Register of June 16, 2005 (70 FR 35097), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0374. The approval expires on September 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at https:// www.fda.gov/ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: October 3, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–20308 Filed 10–7–05; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body’’ has been approved by the Office of VerDate Aug<31>2005 16:40 Oct 07, 2005 Jkt 208001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 [Docket No. 2005D–0401] Draft Guidance for Industry and FDA 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; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘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.’’ The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of enactment (August 1, 2005) identifying the circumstances in which the name, abbreviation, or symbol identifying the manufacturer of an original device is not ‘‘prominent and conspicuous.’’ DATES: Submit written or electronic comments on this draft guidance so that they are received by close of business on November 10, 2005. FDA will not be able to consider comments received after that date in developing the final guidance. FDA may consider late comments at a future time if the E:\FR\FM\11OCN1.SGM 11OCN1 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices guidance needs to be revised at a later date. ADDRESSES: Submit written requests for single copies on a 3.5″ diskette of the guidance document entitled ‘‘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’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–443– 8818. 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.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices and Radiological Health (HFZ–300), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240– 276–0106. SUPPLEMENTARY INFORMATION: I. Background MDUFMA (Public Law 107–250) amended section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a device, or an attachment to the device, 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. This labeling provision applied to all devices and all device manufacturers, including reprocessors. On August 1, 2005, MDUFSA (Public Law 109–43) amended section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Therefore, section 502(u) of the act, as amended by MDUFSA, no longer sets forth requirements for original equipment manufacturers, unless they also reprocess SUDs. Under the amended provision, if an original device or an attachment to it does not prominently and conspicuously bear the name of the manufacturer of the original VerDate Aug<31>2005 16:40 Oct 07, 2005 Jkt 208001 device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, the manufacturer who reprocesses the SUD may identify itself using a detachable label on the packaging of the device. Section 2(c)(2) of MDUFSA requires that FDA issue guidance not later than 180 days after the date of its enactment to identify the circumstances under which the identifying mark of a manufacturer of an original device is not ‘‘prominent and conspicuous,’’ as used in section 502(u) of the act. When finalized, this guidance document will satisfy this MDUFSA requirement. As stated previously, FDA requests that interested person submit their comments on the draft guidance within 30 days of its publication. FDA will consider these comments to determine whether to revise the guidance before issuing it in final form. 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 represent the agency’s current thinking on ‘‘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.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access To receive ‘‘ 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’’ by fax machine, call the CDRH Facts-On-Demand system at 800–899– 0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1217) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 59075 regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). In the Federal Register of September 29, 2005 (70 FR 56910), FDA published a 60-day notice soliciting comments on the information collection provisions contained in this guidance. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this draft guidance. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 3, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–20329 Filed 10–7–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Proposed Information Collection: Final Rule To Implement Title V of the Tribal Self-Governance Amendments of 2000; Request for Public Comment: 30-Day Notice AGENCY: E:\FR\FM\11OCN1.SGM Indian Health Service, HHS. 11OCN1

Agencies

[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Pages 59074-59075]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20329]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0401]


Draft Guidance for Industry and FDA 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; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``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.'' The Medical Device User Fee and Modernization Act of 2002 
(MDUFMA), as amended by the Medical Device User Fee Stabilization Act 
of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of 
enactment (August 1, 2005) identifying the circumstances in which the 
name, abbreviation, or symbol identifying the manufacturer of an 
original device is not ``prominent and conspicuous.''

DATES: Submit written or electronic comments on this draft guidance so 
that they are received by close of business on November 10, 2005. FDA 
will not be able to consider comments received after that date in 
developing the final guidance. FDA may consider late comments at a 
future time if the

[[Page 59075]]

guidance needs to be revised at a later date.

ADDRESSES: Submit written requests for single copies on a 
3.5 diskette of the guidance document entitled ``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'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health, Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-443-8818. 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.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices 
and Radiological Health (HFZ-300), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0106.

SUPPLEMENTARY INFORMATION:

I. Background

    MDUFMA (Public Law 107-250) amended section 502 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a 
device, or an attachment to the device, 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. This labeling provision applied to all 
devices and all device manufacturers, including reprocessors.
    On August 1, 2005, MDUFSA (Public Law 109-43) amended section 
502(u) of the act by limiting the provision to reprocessed single-use 
devices (SUDs) and the manufacturers who reprocess them. Therefore, 
section 502(u) of the act, as amended by MDUFSA, no longer sets forth 
requirements for original equipment manufacturers, unless they also 
reprocess SUDs. Under the amended provision, if an original device or 
an attachment to it does not prominently and conspicuously bear the 
name of the manufacturer of the original device, a generally recognized 
abbreviation of such name, or a unique and generally recognized symbol 
identifying such manufacturer, the manufacturer who reprocesses the SUD 
may identify itself using a detachable label on the packaging of the 
device.
    Section 2(c)(2) of MDUFSA requires that FDA issue guidance not 
later than 180 days after the date of its enactment to identify the 
circumstances under which the identifying mark of a manufacturer of an 
original device is not ``prominent and conspicuous,'' as used in 
section 502(u) of the act. When finalized, this guidance document will 
satisfy this MDUFSA requirement. As stated previously, FDA requests 
that interested person submit their comments on the draft guidance 
within 30 days of its publication. FDA will consider these comments to 
determine whether to revise the guidance before issuing it in final 
form.

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 represent the agency's current thinking on ``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.'' It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    To receive `` 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'' by fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. Press 1 to enter the system. At 
the second voice prompt, press 1 to order a document. Enter the 
document number (1217) followed by the pound sign (). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
https://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at https://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In the Federal 
Register of September 29, 2005 (70 FR 56910), FDA published a 60-day 
notice soliciting comments on the information collection provisions 
contained in this guidance.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this draft 
guidance. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20329 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S

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