13864 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; AIDS and 

AIDS Related Research. 

Date: March 18, 2015. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Jose H Guerrier, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1137, guerriej@csr.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: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Respiratory Sciences Special Panel. 

Date: March 19–20, 2015. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892, (Virtual 

Meeting). 

Contact Person: Lawrence E Boerboom, 

Ph.D., Chief, CVRS IRG, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 4130, MSC 7814, 

Bethesda, MD 20892, (301) 435–8367, 

boerboom@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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Respiratory Sciences Special Panel. 

Date: March 24–25, 2015. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Lawrence E Boerboom, 

Ph.D., Chief, CVRS IRG, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 4130, MSC 7814, 

Bethesda, MD 20892, (301) 435–8367, 

boerboom@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. 

(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) 

Dated: March 11, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–06036 Filed 3–16–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0293] 

Reprocessing Medical Devices in 

Health Care Settings: Validation 

Methods and Labeling; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Reprocessing Medical Devices in 

Health Care Settings: Validation 

Methods and Labeling.’’ This guidance 

provides recommendations for the 

formulation and scientific validation of 

reprocessing instructions for reusable 

medical devices. This guidance 

document also provides 

recommendations for the content and 

review procedures for premarket 

notification (510(k)) submissions, 

premarket approval (PMA) applications, 

humanitarian device exemption (HDE) 

applications, de novo requests, and 

investigational device exemption (IDE) 

applications, concerning the labeling 

instructions for reprocessing reusable 

medical devices. This guidance reflects 

the scientific advances in knowledge 

and technology involved in reprocessing 

reusable medical devices, especially 

more complex, reusable medical device 

designs that are more difficult to 

reprocess. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Reprocessing 

Medical Devices in Health Care Settings: 

Validation Methods and Labeling’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave. Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002; or 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 that office in processing 

your request. 

Submit electronic comments on the 

guidance 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: 

Angela C. Krueger, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1666, Silver Spring, 

MD 20993–0002, 301–796–6380; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, there has been a 

significant advance in knowledge and 

technology involved in reprocessing 

reusable medical devices. Additionally, 

there has been an evolution towards 

more complex medical device designs 

that are more difficult to clean, 

disinfect, and sterilize. This guidance 

reflects the scientific advances in these 

areas. Under section 502(f) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 352(f)), a device must have 

adequate directions for use, which 

include instructions on preparing a 

device for use. Instructions on how to 

reprocess (i.e., clean, disinfect, and 

sterilize) a reusable device are critical to 

ensure that the device is appropriately 

prepared for its next use. 

In the Federal Register of May 2, 2011 

(76 FR 24494), FDA announced the 

availability of the draft guidance. 

Interested persons were invited to 

comment by August 1, 2011. FDA 

reviewed and considered all the public 

comments we received and revised 

several sections of the guidance, where 

applicable. On June 8 and 9, 2011, FDA 

held a public workshop entitled 

‘‘Reprocessing of Reusable Medical 

Devices Workshop.’’ The purpose of the 

workshop was to discuss factors 

affecting the reprocessing of reusable 

medical devices and FDA’s plans to 

address the identified issues. The 

discussion during this workshop and 

the comments received were considered 

before revising the guidance. This final 

guidance supersedes ‘‘Labeling Reusable 

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Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13865 

Medical Devices for Reprocessing in 

Health Care Facilities: FDA Reviewer 

Guidance’’ dated April 1996. 

This final guidance contains the 

addition of ‘‘Appendix E: Devices for 

which a 510(k) Should Contain Data to 

Validate Reprocessing Instructions,’’ 

which includes a subset of medical 

devices that FDA has identified that 

pose a greater likelihood of microbial 

transmission and represent a high risk 

of infection if they are not adequately 

reprocessed. Because of this greater 

public health risk, 510(k) submissions 

for these devices should include 

protocols and complete test reports of 

the validation of the reprocessing 

instructions so that FDA has the 

information it needs to evaluate 

substantial equivalence. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on reprocessing 

validation methods and labeling for 

medical 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 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Reprocessing Medical Devices in 

Health Care Settings: Validation 

Methods and Labeling’’ may send an 

email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1748 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

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 parts 801 and 809 have been 

approved under OMB control number 

0910–0485 (medical device labeling); 

the collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120 

(premarket notification); the collections 

of information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078 (investigational 

device exemption); the collections of 

information in 21 CFR part 814, 

subparts A through E have been 

approved under OMB control number 

0910–0231 (premarket approval); the 

collections of information in 21 CFR 

part 814, subpart H have been approved 

under OMB control number 0910–0332 

(humanitarian use devices); and the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073 

(quality system regulation). 

V. Comments 

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. 

Dated: March 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06029 Filed 3–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request Surveys To Support an 

Evaluation of the National Human 

Genome Research Institute (NHGRI) 

Summer Workshop in Genomics (Short 

Course) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Human Genome Research 

Institute (NHGRI), National Institutes of 

Health (NIH), will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’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 those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments And For 

Further Information: To obtain a copy of 

the data collection plans and 

instruments, submit comments in 

writing, or request more information on 

the proposed project, contact: Carla L. 

Easter, Ph.D., Chief, Education and 

Community Involvement Branch, 

NHGRI, Building 31, Room B1B55, 31 

Center Drive, MSC 2070, Bethesda, MD 

20892 or call non-toll-free number (301) 

594–1364 or Email your request, 

including your address to: easterc@

mail.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Surveys to 

Support an Evaluation of the NHGRI 

Summer Workshop in Genomics (Short 

Course), 0925–NEW, National Human 

Genome Research Institute (NHGRI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: The purpose of the proposed 

data collection activity is to complete a 

full-scale outcome evaluation of 

NHGRI’s Summer Workshop in 

Genomics (a.k.a., the ‘‘Short Course’’) 

focusing on program participants 

between 2004 and 2012. This training 

program is an intensive multi-day 

course that updates instructors and 

researchers of biology and nursing (and 

other related disciplines) on the latest 

research trends and topics in genomic 

science. The course focuses on the 

continuing effort to find the genetic 

basis of various diseases and disorders, 

and current topics on the ethical, legal 

and social implications of genomics. 

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