61644 Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1.101(d) (Non-Tobacco products) ........................................ 73 503 36,719 15 550,785 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1.101(b), (c), and (e) (Non-Tobacco Products ) .................. 320 3 960 22 21,120 

1.101(b) (Non-Tobacco Products for Office of International 

Programs only) ................................................................. 1 189 189 22 4,158 

1.101(b) (Tobacco Products Only) ...................................... 158 3 474 22 10,428 

Total .............................................................................. ........................ ........................ ........................ ........................ 35,706 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24293 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–D–1351] 

Flow Cytometric Devices; Draft 

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availability of the draft guidance 

entitled ‘‘Flow Cytometric Devices.’’ 

This draft guidance addresses the 

current major review concerns regarding 

submissions for flow cytometric devices 

used as in vitro diagnostic devices for 

leukocyte immunophenotyping and 

provides suggestions on the content of 

submissions for these types of devices. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by January 12, 

2015. 

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 draft guidance 

document entitled ‘‘Flow Cytometric 

Devices’’ 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 Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, 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 

draft 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: 

Kevin Maher, Office of In Vitro 

Diagnostics and Radiological Health, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4246, Silver Spring, 

MD 20993–0002, 301–796–6879, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance addresses certain 

issues that arise in premarket 

submissions for flow cytometric devices 

used as in vitro diagnostic devices for 

leukocyte immunophenotyping and 

provides suggestions on the content of 

submissions for these types of devices. 

It is intended to be used in conjunction 

with the other cited guidance 

documents referenced therein. In 

preparing your submission to FDA, we 

recommend that you contact FDA’s 

Office of In Vitro Diagnostics and 

Radiological Health (see FOR FURTHER

INFORMATION CONTACT) for additional 

information regarding your submission. 

This draft guidance focuses on issues 

relevant to flow cytometric devices with 

an expanded scope of review topics that 

reflect the recognition of a flow 

cytometric device as an analytical 

system, which includes processing 

reagents, processing instrumentation, 

flow cytometers, and analytical 

software, in addition to the monoclonal 

antibody (mAb) component. The 

information presented in this draft 

guidance is based on the following: (1) 

Current basic science, (2) clinical 

experience, and (3) previous 

submissions by manufacturers to FDA. 

As advances are made in science and 

medicine, the content of this guidance 

will be re-evaluated and revised as 

necessary to accommodate new 

knowledge. 

This draft guidance is directed toward 

immunophenotyping of leukocytes 

using mAbs. However, the concepts may 

be applicable to related devices that 

utilize fluorochromes or fluorogenic 

substrates to measure ligand binding on 

solid particles in suspension, with or 

without mAbs. This draft guidance does 

not cover microscopy devices utilizing 

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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 

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