Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 62447 

VII. Special Accommodations 

Individuals requiring special 

accommodations must include the 

request for these services during 

registration. 

VIII. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

Panel meeting generally are not final 

until they have been reviewed and 

approved by the Panel on the last day 

of the meeting, before the final 

adjournment. These recommendations 

will be posted to our Web site after the 

meeting. 

IX. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

Dated: October 7, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–24755 Filed 10–16–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

037 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (‘‘FDA Recognized 

Consensus Standards’’). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 037’’ 

(‘‘Recognition List Number: 037’’), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

for the effective date of the recognition 

of standards announced in this 

document. 

ADDRESSES: An electronic copy of 

Recognition List Number: 037 is 

available on the Internet at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI for electronic access to the searchable 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 037 

modifications and other standards 

related information. 

Submit written requests for single 

copies of the document entitled 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

037’’ to the Division of Industry and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 301–847–8149. 

Submit electronic comments on this 

document to http://

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: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3632, Silver Spring, 

MD 20993, 301–796–6287, standards@

cdrh.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) amended section 

514 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d). Amended section 514 allows 

FDA to recognize consensus standards 

developed by international and national 

organizations for use in satisfying 

portions of device premarket review 

submissions or other requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how we would 

implement our standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, can be accessed at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

Agency maintains HTML and PDF 

versions of the list of FDA Recognized 

Consensus Standards. Both versions are 

publicly accessible at the Agency’s 

Internet site. See section VI of this 

document for electronic access 

information. Interested persons should 

review the supplementary information 

sheet for the standard to understand 

fully the extent to which FDA 

recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 037 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the Agency 

will recognize for use in premarket 

submissions and other requirements for 

devices. We will incorporate these 

modifications in the list of FDA 

Recognized Consensus Standards in the 

Agency’s searchable database. We will 

use the term ‘‘Recognition List Number: 

037’’ to identify these current 

modifications. 

In Table 1, we describe the following 

modifications: (1) The withdrawal of 

standards and their replacement by 

others, if applicable, (2) the correction 

of errors made by FDA in listing 

previously recognized standards, and (3) 

the changes to the supplementary 

information sheets of recognized 

standards that describe revisions to the 

applicability of the standards. 

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62448 Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old recognition No. Replacement 

recognition No. Title of standard 1 Change 

A. General I (ES/EMC) 

5–90 ............................. ..................................... ISO 15223–1 Second edition 2012–07–01 Medical devices—Symbols to be used with medical device labels, 

labeling, and information to be supplied—Part 1: General requirements.

Extent of recognition. 

5–91 ............................. ..................................... AAMI/ANSI/ISO 15223–1:2012 Medical devices—Symbols to be used with medical devices labels, labeling, 

and information to be supplied—Part 1: General requirements.

Extent of recognition. 

B. General II (ES/EMC) 

19–1 ............................. ..................................... IEC 60601–1–2 Edition 3: 2007–03 Medical Electrical 

Equipment—Part 1–2: General Requirements for Basic 

Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility—Requirements and 

Tests.

Extent of recognition and transition period. 

19–2 ............................. ..................................... ANSI/AAMI/IEC 60601–1–2:2007/(R)2012 Medical Electrical Equipment—Part 1–2: General requirements for 

basic safety and essential performance—Collateral 

Standard: Electromagnetic compatibility—requirements 

and tests.

Extent of recognition and transition period. 

19–8 ............................. ..................................... IEC 60601–1–2 Edition 4.0 2014–02 Medical electrical 

equipment—Part 1–2: General requirements for basic 

safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and 

tests.

Transition period extended. 

C. In Vitro Diagnostics 

7–246 ........................... ..................................... CLSI POCT12–A3 Point-of-Care Blood Glucose Testing 

in Acute and Chronic Care Facilities; Approved Guideline—Third Edition.

Withdrawn. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

III. Listing of New Entries 

In Table 2 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 037. 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of standard 1 Reference No. and date 

A. General II (ES/EMC) 

19–12 ................................... Medical electrical equipment—Part 1–2: General requirements for 

basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests.

ANSI/AAMI/IEC 60601–1–2:2014. 

19–13 ................................... Secondary cells and batteries containing alkaline or other non-acid 

electrolytes—Safety requirements for portable sealed secondary 

cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)].

IEC 62133 Edition 2.0 2012–12. 

B. OB–GYN/Gastroenterology 

9–95 ..................................... Enteral Feeding Catheters and Enteral Giving Sets for Single Use 

and their Connectors—Design and Testing.

EN 1615:2000. 

9–96 ..................................... Catheters Other Than Intravascular Catheters—Test Methods for 

Common Properties.

EN 1618:1997. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the Agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http://

www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

revisions described in this notice into 

the database and, upon publication in 

the Federal Register, this recognition of 

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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 62449 

consensus standards will be effective. 

FDA will announce additional 

modifications and revisions to the list of 

recognized consensus standards, as 

needed, in the Federal Register once a 

year, or more often if necessary. 

Beginning with Recognition List 033, 

FDA no longer announces minor 

revisions to the list of recognized 

consensus standards such as technical 

contact person, devices affected, 

processes affected, Code of Federal 

Regulations citations, and product 

codes. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to standards@

cdrh.fda.gov. To be properly considered, 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. The Center for Devices and 

Radiological Health (CDRH) maintains a 

site on the Internet for easy access to 

information including text, graphics, 

and files that you may download to a 

personal computer with access to the 

Internet. Updated on a regular basis, the 

CDRH home page, http://www.fda.gov/

MedicalDevices, includes a link to 

standards-related documents including 

the guidance and the current list of 

recognized standards. After publication 

in the Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 037’’ will be available at 

http: 

//www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/

MedicalDevices/

DeviceRegulationandGuidance/

Standards. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit either 

electronic comments regarding this 

document to http://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 

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 http://

www.regulations.gov. FDA will consider 

any comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

037. These modifications to the list of 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: October 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24714 Filed 10–16–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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. 

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: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis NIAAA Member Conflict 

Applications—Biomedical Sciences. 

Date: October 28, 2014. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

proposals. 

Place: NIAAA, 5635 Fishers Lane; Room 

2085, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch, 

National Institute on Alcohol Abuse and 

Alcoholism, NIH, 5365 Fishers Lane; Room 

2085, Rockville, MD 20852, (301) 451–2067, 

srinivar@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis NIAAA Member Conflict 

Applications—Epidemiology & Behavioral 

Sciences. 

Date: October 30, 2014. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

proposals. 

Place: NIAAA, 5635 Fishers Lane; Room 

2085, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch, 

National Institute on Alcohol Abuse and 

Alcoholism, NIH, 5365 Fishers Lane; Room 

2085, Rockville, MD 20852, (301) 451–2067, 

srinivar@mail.nih.gov 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis NIAAA Member Conflict 

Applications—Treatment and Health 

Services. 

Date: November 5, 2014. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

proposals. 

Place: NIAAA, 5635 Fishers Lane; Room 

2085, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch, 

National Institute on Alcohol Abuse and 

Alcoholism, NIH, 5365 Fishers Lane; Room 

2085, Rockville, MD 20852, (301) 451–2067, 

srinivar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 92.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Supports Awards, National 

Institutes of Health, HHS) 

Dated: October 14, 2014. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–24790 Filed 10–16–14; 8:45 am] 

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