13586 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Jingsheng Tuo, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

Bethesda, MD 20892, 301–451–8754, tuoj@

nei.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 10, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05824 Filed 3–13–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Child Care Quarterly Case 

Record Report—ACF–801. 

OMB No.: 0970–0167. 

Description: Section 658K of the Child 

Care and Development Block Grant Act 

(42 U.S.C. 9858) requires that States and 

Territories submit monthly case-level 

data on the children and families 

receiving direct services under the Child 

Care and Development Fund (CCDF). 

The implementing regulations for the 

statutorily required reporting are at 45 

CFR 98.70. Case-level reports, submitted 

quarterly or monthly (at grantee option), 

include monthly sample or full 

population case-level data. The data 

elements to be included in these reports 

are represented in the ACF–801. ACF 

uses disaggregate data to determine 

program and participant characteristics 

as well as costs and levels of child care 

services provided. This provides ACF 

with the information necessary to make 

reports to Congress, address national 

child care needs, offer technical 

assistance to grantees, meet performance 

measures, and conduct research. On 

November 19, 2014, the President 

signed the Child Care and Development 

Block Grant Act of 2014 (Pub. L. 113– 

86) which reauthorized the CCDF 

program and made some changes to 

ACF–801 reporting requirements. 

Owing to the need to consult with CCDF 

administrators and other interested 

parties on these changes, and a limited 

amount of time before the current ACF– 

801 form expires, ACF is not proposing 

changes to the ACF–801 at this time. We 

request to extend the ACF–801 without 

changes in order to ensure the form does 

not expire. In the near future, ACF plans 

to initiate a new clearance process 

under the Paperwork Reduction Act to 

implement the data reporting changes in 

the newly-reauthorized law. 

Respondents: States, the District of 

Columbia, and Territories including 

Puerto Rico, Guam, the Virgin Islands, 

American Samoa, and the Northern 

Marianna Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

ACF–801 .......................................................................................................... 56 4 25 5,600 

Estimated total annual burden hour ......................................................... ........................ ........................ ........................ 5,600 

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, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–05918 Filed 3–13–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0793] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Recall Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

for medical device recall authority. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 15, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 


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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices 13587 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Device Recall Authority—21 

CFR 810 (OMB Control Number 0910– 

0432)—Extension 

This collection of information 

implements section 518(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360h(e)) and part 

810 (21 CFR part 810), medical device 

recall authority provisions. Section 

518(e) of the FD&C Act provides FDA 

with the authority to issue an order 

requiring an appropriate person, 

including manufacturers, importers, 

distributors, and retailers of a device, if 

FDA finds that there is reasonable 

probability that the device intended for 

human use would cause serious adverse 

health consequences or death, to: (1) 

Immediately cease distribution of such 

device; (2) immediately notify health 

professionals and device-user facilities 

of the order; and (3) instruct such 

professionals and facilities to cease use 

of such device. 

Further, the provisions under section 

518(e) of the FD&C Act set out the 

following three-step procedure for 

issuance of a mandatory device recall 

order: 

• If there is a reasonable probability 

that a device intended for human use 

would cause serious, adverse health 

consequences or death, FDA may issue 

a cease distribution and notification 

order requiring the appropriate person 

to immediately: 

Æ Cease distribution of the device, 

Æ notify health professionals and 

device user facilities of the order, and 

Æ instruct those professionals and 

facilities to cease use of the device; 

• FDA will provide the person named 

in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be modified, vacated, or 

amended to require a mandatory recall 

of the device; and 

• after providing the opportunity for 

an informal hearing, FDA may issue a 

mandatory recall order if the Agency 

determines that such an order is 

necessary. 

The information collected under the 

recall authority provisions will be used 

by FDA to do the following: (1) Ensure 

that all devices entering the market are 

safe and effective; (2) accurately and 

immediately detect serious problems 

with medical devices; and (3) remove 

dangerous and defective devices from 

the market. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Collection activity—21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Collections Specified in the Order—810.10(d) .................... 2 1 2 8 16 

Request for Regulatory Hearing—810.11(a) ....................... 1 1 1 8 8 

Written Request for Review—810.12(a–b) .......................... 1 1 1 8 8 

Mandatory Recall Strategy—810.14 .................................... 2 1 2 16 32 

Periodic Status Reports—810.16(a–b) ................................ 2 12 24 40 960 

Termination Request—810.17(a) ......................................... 2 1 2 8 16 

Total hours .................................................................... ........................ ........................ ........................ ........................ 1,040 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Collection activity—21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

Total hours 

Documentation of Notifications to Recipients—810.15(b) ... 2 1 1 8 8 

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


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13588 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Collection activity—21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification to Recipients—810.15(a)–(c) ............................ 2 1 2 12 24 

Notification to Recipients; Followup—810.15(d) .................. 2 1 2 4 8 

Notification of Consignees by Recipients—810.15(e) ......... 10 1 10 1 10 

Total .............................................................................. ........................ ........................ ........................ ........................ 42 

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

Dated: March 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05868 Filed 3–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2015–0001] 

Final Flood Hazard Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final notice. 

SUMMARY: Flood hazard determinations, 

which may include additions or 

modifications of Base Flood Elevations 

(BFEs), base flood depths, Special Flood 

Hazard Area (SFHA) boundaries or zone 

designations, or regulatory floodways on 

the Flood Insurance Rate Maps (FIRMs) 

and where applicable, in the supporting 

Flood Insurance Study (FIS) reports 

have been made final for the 

communities listed in the table below. 

The FIRM and FIS report are the basis 

of the floodplain management measures 

that a community is required either to 

adopt or to show evidence of having in 

effect in order to qualify or remain 

qualified for participation in the Federal 

Emergency Management Agency’s 

(FEMA’s) National Flood Insurance 

Program (NFIP). In addition, the FIRM 

and FIS report are used by insurance 

agents and others to calculate 

appropriate flood insurance premium 

rates for buildings and the contents of 

those buildings. 

DATES: The effective date of January 7, 

2015 which has been established for the 

FIRM and, where applicable, the 

supporting FIS report showing the new 

or modified flood hazard information 

for each community. 

ADDRESSES: The FIRM, and if 

applicable, the FIS report containing the 

final flood hazard information for each 

community is available for inspection at 

the respective Community Map 

Repository address listed in the tables 

below and will be available online 

through the FEMA Map Service Center 

at www.msc.fema.gov by the effective 

date indicated above. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, FEMA, 

500 C Street SW., Washington, DC 

20472, (202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov; or visit 

the FEMA Map Information eXchange 

(FMIX) online at 

www.floodmaps.fema.gov/fhm/fmx_

main.html. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the new or modified 

flood hazard information for each 

community listed. Notification of these 

changes has been published in 

newspapers of local circulation and 90 

days have elapsed since that 

publication. The Deputy Associate 

Adminstrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

This final notice is issued in 

accordance with section 110 of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4104, and 44 CFR part 67. 

FEMA has developed criteria for 

floodplain management in floodprone 

areas in accordance with 44 CFR part 

60. 

Interested lessees and owners of real 

property are encouraged to review the 

new or revised FIRM and FIS report 

available at the address cited below for 

each community or online through the 

FEMA Map Service Center at 

www.msc.fema.gov. 

The flood hazard determinations are 

made final in the watersheds and/or 

communities listed in the table below. 

(Catalog of Federal Domestic Assistance No. 

97.022, ‘‘Flood Insurance.’’) 

Dated: February 23, 2015. 

Roy E. Wright, 

Deputy Associate Administrator for 

Mitigation, Department of Homeland 

Security, Federal Emergency Management 

Agency. 

Community Community map repository address 

Floyd County, Iowa and Incorporated Areas 

Docket No.: FEMA–B–1342 

City of Charles City .................................................................................. City Hall, 105 Milwaukee Mall, Charles City, IA 50616. 

Unincorporated Areas of Floyd County .................................................... Floyd County Courthouse, 101 South Main Street, Suite 108, Charles 

City, IA 50616. 


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