Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 61645 

fluorescent or chromogenic enzymesubstrate detection methods (e.g., 

immunohistochemical stains) nor does 

it cover the use of flow cytometry for 

cell enrichment and cell sorting/

purification when used in cell therapy 

product manufacturing. 

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This draft guidance is being issued 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The draft guidance, when finalized, will 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 flow cytometric 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of the draft guidance may do so by 

downloading an electronic copy from 

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.regulations.gov or from 

CBER at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Persons unable to download an 

electronic copy of ‘‘Flow Cytometric 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 1787 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 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 807, 

subpart E, have been approved under 

OMB control number 0910–0120, and 

the collections of information in 21 CFR 

part 801 and 21 CFR 809.10 have been 

approved under OMB control number 

0910–0485. 

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: October 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24308 Filed 10–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Society of Clinical Research 

Associates—Food and Drug 

Administration: Food and Drug 

Administration Clinical Trial 

Requirements, Regulations, 

Compliance, and Good Clinical 

Practice; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing an educational 

conference co-sponsored with the 

Society of Clinical Research Associates 

(SoCRA). The public workshop 

regarding FDA’s clinical trial 

requirements is designed to aid the 

clinical research professional’s 

understanding of the mission, 

responsibilities, and authority of FDA 

and to facilitate interaction with FDA 

representatives. The program will focus 

on the relationships among FDA and 

clinical trial staff, investigators, and 

institutional review boards (IRB). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; as well as inspections of 

clinical investigators, IRB, and research 

sponsors. 

Date and Time: The public workshop 

will be held on November 5 and 6, 2014, 

from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Wyndham Lake Buena 

Vista Hotel, 1850 Hotel Plaza Blvd., 

Lake Buena Vista, FL 32830, 407–828– 

4444. 

Attendees are responsible for their 

own accommodations. Please mention 

SoCRA to receive the hotel room rate of 

$95.00 plus applicable taxes (available 

until October 6, 2014, or until the 

SoCRA room block is filled). 

Contact: C. Stewart Watson, Food and 

Drug Administration, 555 Winderley Pl., 

Suite 200, Maitland, FL 32751, 407– 

475–4756, FAX: 407–475–4768, or 

Society of Clinical Research Associates 

(SoCRA), 530 West Butler Ave., Suite 

109, Chalfont, PA 18914, 800–762–7292 

or 215–822–8644, FAX: 215–822–8633, 

email SoCRAmail@aol.com, Web site: 

www.socra.org. 

Registration: The registration fee will 

cover actual expenses including 

refreshments, lunch, materials and 

speaker expenses. Seats are limited; 

please submit your registration as soon 

as possible. Workshop space will be 

filled in order of receipt of registration. 

Those accepted into the workshop will 

receive confirmation. The cost of the 

registration is as follows: SoCRA 

member—$575; SoCRA nonmember 

(includes membership)—$650; Federal 

Government member—$450.00; Federal 

Government SoCRA nonmember— 

$525.00; FDA Employee—Fee Waived. 

If you need special accommodations 

due to a disability, please contact 

SoCRA (see Contact) at least 21 days in 

advance. 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. 

SoCRA designates this education 

activity for a maximum of 13.3 

continuing education (CE) credits for 

SoCRA CE and continuing nursing 

education (CNE). SoCRA designates this 

live activity for a maximum of 13.3 

American Medical Association 

Physicians Recognition Award Category 

1 Credit(s).TM Physicians should claim 

only the credit commensurate with the 

extent of their participation. Continuing 

Medical Education for physicians: 

SoCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for nurses: SoCRA is an 

approved provider of continuing 

nursing education by the Pennsylvania 

State Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation (ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SoCRA’’. Mail to: SoCRA (see Contact 

for address). To register via the Internet, 

go to http://www.socra.org/html/FDA_

Conference.htm. (FDA has verified the 

Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

mstockstill on DSK4VPTVN1PROD with NOTICES

61646 Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 

sites after this document is published in 

the Federal Register.) Payment by major 

credit card is accepted (Visa/

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SoCRA (see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The public 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related 

informed consent, clinical investigation 

requirements, institutional review board 

inspections, electronic record 

requirements, and investigator initiated 

research Topics for discussion include 

the following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program 

(BIMO); (2) Modernizing FDA’s Clinical 

Trials/BIMO Programs; (3) What FDA 

Expects in a Pharmaceutical Clinical 

Trial; (4) Medical Device Aspects of 

Clinical Research; (5) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (6) Working with FDA’s 

Center for Biologics Evaluation and 

Research; (7) Ethical Issues in Subject 

Enrollment; (8) Keeping Informed and 

Working Together; (9) FDA Conduct of 

Clinical Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings with FDA—Why, When, and 

How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; (16) Question and Answer 

Session/Panel Discussion. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393), which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The workshop also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

Government agencies to small 

businesses. 

Dated: October 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24307 Filed 10–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Evaluation of 

National Institutes of Health 

International Bilateral Programs (FIC, 

NCI, NIAAA, NIAID, NICHD, NIDA, 

NINDS, NIMH, OAR) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on March 13, 2014 

(Vol. 79, P. 14256) and allowed 60-days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

DATES: Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Margaret Mary Bertram, Center 

for Global Health, National Cancer 

Institute, 9609 Medical Center Dr., Rm 

3W264, Rockville MD, 20850 or call 

non-toll-free number 240–276–5656 or 

Email your request, including your 

address to: margaret.bertram@nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: Evaluation of 

National Institutes of Health 

International Bilateral Programs (FIC, 

NCI, NIAAA, NIAID, NICHD, NIDA, 

NINDS, NIMH, OAR), 0925–NEW, 

National Cancer Institute (NCI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: This submission is a request 

for OMB to approve the Evaluation of 

National Institutes of Health (NIH) 

International Bilateral Programs for 

three years. The bilateral awards are 

made through the Funding Opportunity 

Announcement mechanism and 

administrative supplements, meaning 

they are funded by set-aside funds that 

are separate from the general pool of 

research program grant funds used to 

support investigator initiated research at 

NIH. The bilateral programs to be 

evaluated are the U.S.-China Program 

for Biomedical Research Cooperation, 

U.S.-India Bilateral Collaborative 

Research Partnerships on the Prevention 

of HIV/AIDS and Co-morbidities, U.S.- 

Russia Bilateral Collaborative Research 

Partnerships on the Prevention and 

Treatment of HIV/AIDS and Comorbidities, and U.S.-South Africa 

Program for Collaborative Biomedical 

Research. These programs are funded 

and administered by various 

combinations of the following institutes: 

Fogarty International Center (FIC), the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development (NICHD), National Cancer 

Institute (NCI), National Institute on 

Alcohol Abuse and Alcoholism 

(NIAAA), National Institute for Allergy 

and Infectious Diseases (NIAID), 

National Institute on Drug Abuse 

(NIDA), National Institute of Mental 

Health (NIMH), National Institute of 

Neurological Disorders and Stroke 

(NINDS), and the Office of AIDS 

Research (OAR). While these programs 

differ, their underlying concept is the 

same; they require U.S. scientists to 

collaborate with scientists from other 

countries in order to conduct 

scientifically meritorious investigations 

of mutual interest to both countries. The 

proposed evaluation requests 

information about (1) accomplishments 

of the awards, (2) unique findings or 

opportunities due to the international 

collaborations, and (3) successes and 

challenges of these collaborations. The 

information will be collected one year 

into the award and at the end of the 

award, when possible. This information 

is needed to evaluate the effectiveness 

of these programs across NIH. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

129. 

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