Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry; Availability, 53712-53713 [2014-21480]

Download as PDF 53712 Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Notices to complete the interview, for a total of 18 hours. Prior to the administration of the Health and Diet Survey, the Agency plans to conduct a pretest to identify and resolve potential survey administration problems. We will use a pretest screener with 2,000 individuals; we estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the pretest screener, for a total of 66 hours. The pretest will be conducted with 200 participants; we estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 50 hours. We will use a survey screener to select an eligible adult respondent in each household reached by landline telephone numbers to participate in the survey. A total of 30,000 individuals in the 50 states and the District of Columbia will be screened by telephone. We estimate that it will take a respondent 2 minutes (0.033 hours) to complete the screening, for a total of 990 hours. We estimate that 3,000 eligible adults will participate in the survey, each taking 15 minutes (0.25 hours), for a total of 750 hours. Thus, the total estimated burden is 1,882 hours. We are requesting this burden for unplanned surveys so as not to restrict our ability to gather information on consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. This ability will help the Agency identify and respond to emerging issues in a more timely manner. Guide’’ for a final rule published in the Federal Register of September 2013. This small entity compliance guide (SECG) intends to provide, in plain language, the requirements of the regulation and to help small businesses understand and comply with the regulation. Food and Drug Administration Submit either electronic or written comments on the SECG at any time. ADDRESSES: Submit written requests for single copies of the SECG entitled ‘‘Unique Device Identification System: Small Entity Compliance Guide’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist the office in processing your requests. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For CDRH questions regarding this document, contact UDI Regulatory Policy Support, 301–796–5995, email: udi@fda.hhs.gov. For CBER questions regarding this document, contact Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2014–D–1182] I. Background Dated: September 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21532 Filed 9–9–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry; Availability tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Unique Device Identification System: Small Entity Compliance SUMMARY: VerDate Mar<15>2010 19:04 Sep 09, 2014 Jkt 232001 DATES: FDA is announcing the availability of a document entitled: ‘‘Unique Device Identification System: Small Entity Compliance Guide.’’ Section 226 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–85) and section 614 of the Food and Drug Administration Safety and Innovation Act (Pub. L.112– 144) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f) (21 U.S.C. 360i(f)), which directs FDA to issue regulations establishing a unique PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 device identification system for medical devices. In the Federal Register of September 24, 2013 (78 FR 58785), FDA published a final rule establishing a unique device identification system (the UDI Rule). Some parts of the rule became effective on October 24, 2013; the remaining parts became effective on December 23, 2013. In addition, certain provisions within the rule have later compliance dates. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), FDA is making available this SECG stating in plain language the legal requirements of the September 24, 2013, final rule. This level 2 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the Agency’s current thinking on this topic. 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 statutes and regulations. II. Paperwork Reduction Act This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 801 and 830 have been approved under OMB control number 0910–0720; the collections of information in part 803 have been approved under OMB control number 0910–0437; the collections of information in part 806 have been approved under OMB control number 0910–0359; the collections of information in part 810 have been approved under OMB control number 0910–0432; the collections of information in part 814 have been approved under 0910–0231; the collections of information in part 821 have been approved under OMB control number 0910–0442; and the collections of information in part 822 have been approved under OMB control number 0910–0449. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the E:\FR\FM\10SEN1.SGM 10SEN1 Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Notices 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, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at https://www.regulations.gov, https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm, or https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Persons unable to download an electronic copy of ‘‘Unique Device Identification System: Small Entity Compliance Guide’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400046 to identify the guidance you are requesting. Dated: September 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21480 Filed 9–9–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting Health Resources and Services Administration (HRSA), HHS. ACTION: Notice; correction. AGENCY: HRSA published a notice in the Federal Register, FR 2014–18735 (August 8, 2014), announcing the meeting of the National Advisory Committee on Rural Health and Human Services in Sioux Falls, South Dakota (Federal Register, Vol. 79, No. 153, 46445). The site for the opening of the meeting has been changed. FOR FURTHER INFORMATION CONTACT: Steve Hirsch, MSLS, Executive Secretary, National Advisory Committee on Rural Health and Human Services, HRSA, Parklawn Building, 17W61, 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 443–0835, Fax (301) 443–2803, or email at shirsch@hrsa.gov. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: Correction In the Federal Register of August 8, 2014, in FR Doc. 2014–18735, on page VerDate Mar<15>2010 19:04 Sep 09, 2014 Jkt 232001 44645, in column 3, correct the ‘‘PLACE’’ section to read: The meeting on September 24, 2014, will begin at the address below at 8:45 a.m.: Holiday Inn Sioux Falls-City Centre, 100 West 8th Street, Sioux Falls, SD 57104, (605) 339–2000. The meetings on both September 25 and 26 will take place as previously announced at Avera eHelm, 4500 N Lewis Ave, Sioux Falls, SD 57104, (605) 322–4669. Dated: September 4, 2014. Jackie Painter, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2014–21553 Filed 9–9–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Correction for Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting The National Institutes of Health (NIH) is correcting a notice previously published in the Federal Register on August 28, 2014 (79 FR 51344) and titled ‘‘Notice of Intent to Prepare an Environmental Impact Statement and Notice of Scoping Meeting.’’ The notice announced that the National Institutes of Health (NIH) was preparing an environmental impact statement for the Assure/Expand Chilled Water Capacity project located on the National Institutes of Health, Bethesda Campus, Bethesda, Maryland. NIH is amending the date of the meeting from September 24, 2014 to October 2, 2014. For further information about the meeting, please contact Mark Radtke at 301–451–6467. Dated: September 3, 2014. Daniel G. Wheeland, Director, Office of Research Facilities Development and Operations, National Institutes of Health. [FR Doc. 2014–21540 Filed 9–9–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 53713 The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–14– 085: Metabolic Reprogramming in Immunotherapy. Date: September 29, 2014. Time: 8:00 a.m. to 9:30 a.m. Agenda: To review and evaluate grant applications. Place: The Embassy Row Hotel, 2015 Massachusetts Avenue NW., Washington, DC 20036. Contact Person: Denise R Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301–435– 0198, shawdeni@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special: Pilot Clinical Studies in Nephrology. Date: October 1–2, 2014. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Atul Sahai, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2188, MSC 7818, Bethesda, MD 20892, 301–435– 1198, sahaia@csr.nih.gov. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Biology Development and Disease Study Section. Date: October 2–3, 2014. Time: 7:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Torrance Marriott South Bay, 3635 Fashion Way, Torrance, CA 90503. Contact Person: Aruna K Behera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301–435– 6809, beheraak@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) E:\FR\FM\10SEN1.SGM 10SEN1

Agencies

[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53712-53713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21480]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1182]

Unique Device Identification System: Small Entity Compliance
Guide; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Unique Device
Identification System: Small Entity Compliance Guide'' for a final rule
published in the Federal Register of September 2013. This small entity
compliance guide (SECG) intends to provide, in plain language, the
requirements of the regulation and to help small businesses understand
and comply with the regulation.

DATES: Submit either electronic or written comments on the SECG at any
time.

ADDRESSES: Submit written requests for single copies of the SECG
entitled ``Unique Device Identification System: Small Entity Compliance
Guide'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health (CDRH), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002 or to the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist the office in processing your requests.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For CDRH questions regarding this
document, contact UDI Regulatory Policy Support, 301-796-5995, email:
udi@fda.hhs.gov. For CBER questions regarding this document, contact
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled: ``Unique
Device Identification System: Small Entity Compliance Guide.''
Section 226 of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85) and section 614 of the Food and Drug
Administration Safety and Innovation Act (Pub. L.112-144) amended the
Federal Food, Drug, and Cosmetic Act to add section 519(f) (21 U.S.C.
360i(f)), which directs FDA to issue regulations establishing a unique
device identification system for medical devices.
In the Federal Register of September 24, 2013 (78 FR 58785), FDA
published a final rule establishing a unique device identification
system (the UDI Rule). Some parts of the rule became effective on
October 24, 2013; the remaining parts became effective on December 23,
2013. In addition, certain provisions within the rule have later
compliance dates. In compliance with section 212 of the Small Business
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FDA is
making available this SECG stating in plain language the legal
requirements of the September 24, 2013, final rule.
This level 2 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
represents the Agency's current thinking on this topic. 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 statutes and
regulations.

II. Paperwork Reduction Act

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 and 830 have been
approved under OMB control number 0910-0720; the collections of
information in part 803 have been approved under OMB control number
0910-0437; the collections of information in part 806 have been
approved under OMB control number 0910-0359; the collections of
information in part 810 have been approved under OMB control number
0910-0432; the collections of information in part 814 have been
approved under 0910-0231; the collections of information in part 821
have been approved under OMB control number 0910-0442; and the
collections of information in part 822 have been approved under OMB
control number 0910-0449.

III. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the

[[Page 53713]]

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, and will be posted to
the docket at https://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain an electronic
version of the guidance at https://www.regulations.gov, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Persons unable to download an electronic
copy of ``Unique Device Identification System: Small Entity Compliance
Guide'' may send an email request to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the document. Please use the document
number 1400046 to identify the guidance you are requesting.

Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21480 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P

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