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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

13866 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 

The Education and Community 

Involvement Branch (ECIB) designed the 

program to accomplish the following 

goals, which align with elements of both 

the NIH and NHGRI missions: 

• Expand NIH and NHGRI’s 

professional network to reach out to 

diverse communities, and to create new 

partnership opportunities. 

• Prepare the next generation of 

genomics professionals for an era of 

genomic medicine. 

• Train and diversify the pipeline of 

genome professionals in alignment with 

the NIH and US Department of Health 

and Human Services diversity efforts. 

The ECIB has systematically collected 

feedback annually after the program 

from participants since inception of the 

Short Course in 2003, and then used the 

data to tweak the program, but it has not 

conducted a long-term, cumulative and 

substantive outcome evaluation. NHGRI 

and the ECIB propose to conduct such 

an outcome evaluation, focusing on 

three main objectives: 

(1) To understand the degree of 

genetic and genomic curriculum 

integration by faculty participants; 

(2) To explore the barriers and 

supports faculty experience and changes 

when integrating curriculum; and 

(3) To investigate the influence of the 

program on the participants’ career 

path. 

Survey findings will provide valuable 

information about the various methods 

and pathways instructors use to 

disseminate new knowledge (and the 

associated timelines), the barriers and 

supports experienced by faculty as they 

integrate new knowledge into their 

teaching, and insights about additional 

avenues of support that NHGRI could 

provide teaching faculty from the types 

of institutions identified. Key indicators 

will also provide evidence about the 

degree to which the Short Course is 

meeting its goals. Collectively, the 

outcome evaluation will inform future 

program design and budget allocations. 

OMB approval is requested for 2 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

155. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of 

respondents 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

annual 

burden 

hours 

Short Course Survey—Students ..................................... Students ............................. 110 1 30/60 55 

Short Course Survey—Faculty ........................................ Faculty ............................... 200 1 30/60 100 

Totals ........................................................................ ............................................ 310 .................... .................... 155 

Dated: March 11, 2015. 

Gloria Butler, 

NHGRI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2015–06086 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–2015–N–0001] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Vaccines and 

Related Biological Products Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 12, 2015, from 8:30 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. For those 

unable to attend in person, the meeting 

will also be Web cast and will be 

available at the following link: https:// 

collaboration.fda.gov/vrbpac0515/. 

Contact Person: Sujata Vijh, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6128, Silver Spring, MD 209930–0002, 

240–402–7107; or Denise Royster, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6134, Silver Spring, 

MD 209930–0002, 240–402–8158; or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On May 12, 2015, from 8:30 

a.m. to 5 p.m., the committee will meet 

in open session to discuss the 

development and licensure of Ebola 

vaccines. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 5, 2015. Oral 

presentations from the public will be 

scheduled between 1:15 p.m. and 2:15 

p.m. Those individuals interested in 

making formal oral presentations should 

mstockstill on DSK4VPTVN1PROD with NOTICES