Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 61643 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Title Amendments ............................................................................................ 18 1 3 54 

State TANF plan .............................................................................................. 18 1 30 540 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 594 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–24329 Filed 10–10–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0801] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Exports: 

Notification and Recordkeeping 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

13, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0482. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Exports: Notification and 

Recordkeeping Requirements—21 CFR 

1.101 (OMB Control Number 0910– 

0482)—Extension 

Section 801 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 381) charges the Secretary of 

Health and Human Services, through 

FDA, with the responsibility of assuring 

exports (Exports: Notification and 

Recordkeeping Requirements—§ 1.101 

(21 CFR 1.101)) which pertain to the 

exportation of unapproved new drugs, 

biologics, devices, animal drugs, food, 

cosmetics, and tobacco products that are 

not to be sold in the United States. 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or marketed in the United States as 

allowed under section 801(e) of the 

FD&C Act. In general, the notification 

identifies the product being exported 

(e.g. name, description, and in some 

cases, country of destination) and 

specifies where the notifications were 

sent. These notifications are sent only 

for an initial export. Subsequent exports 

of the same product to the same 

destination or in the case of certain 

countries identified in section 802(b) of 

the FD&C Act (21 U.S.C. 382) would not 

result in a notification to FDA. 

The recordkeepers to this information 

collection are exporters who export 

human drugs, biologics, devices, animal 

drugs, foods, cosmetics, and tobacco 

products that may not be sold in the 

United States and maintain records 

demonstrating their compliance with 

the requirements in section 801(e)(1) of 

the FD&C Act. 

On March 30, 2012, OMB approved 

‘‘Further Amendments to General 

Regulations of the Food and Drug 

Administration to Incorporate Tobacco 

Products,’’ OMB control number 0910– 

0690, which amended, among other 

sections, § 1.101 to incorporate tobacco 

products. This amendment reflects the 

Agency’s authority over tobacco 

products under the Family Smoking 

Prevention and Tobacco Control Act 

(Pub. L. 111–31) and added tobacco 

products to the list of products covered 

under § 1.101(a) and (b). 

In the Federal Register of July 3, 2014 

(79 FR 38036), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

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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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