63126 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Private sector health care providers ............... PPOD Guide and Toolkit Follow-up Survey .. 80 1 10/60 

New Beginnings Assessment Survey ............ 700 1 15/60 

State and Local government health care providers and health education facilitators.PPOD Guide and Toolkit Follow-up Survey .. 80 1 10/60 

New Beginnings Assessment Survey ............ 100 1 15/60 

Federal Government health care providers .... PPOD Guide and Toolkit Follow-up Survey .. 40 1 10/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–25095 Filed 10–21–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Intent To Award Ebola 

Response Outbreak Funding to 

Eligible Ministries of Health and Their 

Bona Fide Agents 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice provides public 

announcement of CDC’s intent to award 

Ebola appropriations to select Ministries 

of Health and their bona fide agents for 

response to the Ebola outbreak funding. 

This award was proposed in Fiscal Year 

(FY) 2015 under funding opportunity 

announcement GH14–1418, ‘‘Protecting 

and Strengthening Public Health 

Impact, Systems, Capacity, and 

Security.’’ 

Catalogue of Federal Domestic Assistance 

Number (CFDA): 93.318 

Authority: Public Health Service 301(a) 

and 307 as amended [42 U.S.C. 241 and 242l] 

Multiple awards may be awarded to 

grantees totaling $2,000,000 for Ebola 

response outbreak. 

Funding is appropriated under the 

Continuing Appropriations Resolution, 

2015, Public Law 113–164, 128 Stat. 

1867 (2014). 

DATES: Anticipated award date 10/30/

2014 through 09/29/2015. 

Application Due Date: 10/23/2014 

Project Number is CDC–RFA–GH14– 

1418. 

ADDRESSES: CDC has waived the 

Grants.gov electronic submission 

process for this requirement. Recipients 

are hereby authorized to submit a paper 

copy application for (CDC–RFA–GH14– 

1418) via Express Mail (i.e. FedEx, UPS, 

or DHL) and send the application via 

email. Mailed applications must be 

address to Arthur C. Lusby, Centers for 

Disease Control and Prevention, 2920 

Brandywine Road, Atlanta, GA 30341, 

telephone (770) 488–2865, or email him 

at ALusby@cdc.gov. The application 

must include a detailed line-item budget 

and justification to support the Ebola 

activities from October 31, 2014 to 

September 29, 2015. 

Please download the following to 

complete the application package: 

http://apply07.grants.gov/apply/forms/

sample/SF424_2_1-V2.1.pdf— 

Application Package 

http://www.cdc.gov/od/pgo/funding/

docs/CertificationsForm.pdf— 

Certifications 

http://www.cdc.gov/od/pgo/funding/

grants/Budget_Preparation_

Guidelines_8-2-12.docx—CDC–PGO 

Budget Guidelines 

http://apply07.grants.gov/apply/forms/

sample/SF424A-V1.0.pdf—SF–424A 

Budget Information 

All applications must be submitted to 

and received by the Grants Management 

Officer (GMO) no later than 11:59 p.m. 

EST on October 23, 2014 and please 

provide the GMO a PDF version of the 

application by email to the following 

email address: pgoebolaresponse@

cdc.gov subject line: CDC–RFA–GH14– 

1418. 

Applicants will be provided with the 

Funding Opportunity Announcement 

(FOA) and additional application 

submission guidance via email 

notification. Applicants may contact the 

POCs listed with questions regarding 

the application process. 

FOR FURTHER INFORMATION CONTACT: 

For Programmatic or Technical 

Assistance 

Kawi Mailutha, Project Officer, 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention, 1600 Clifton Rd MS E– 

29, Atlanta, GA 30333, Telephone: 404– 

639–8093, E-Mail: KMailutha@cdc.gov. 

For financial, awards management, or 

budget assistance: Arthur C. Lusby, 

Grants Management Officer, Centers for 

Disease Control and Prevention, 2920 

Brandywine Road, Atlanta, GA 30341, 

Telephone (770) 488–2865, Email: 

ALusby@cdc.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of this notice is to solicit 

applications from eligible Ministries of 

Health and their bona fide agents to 

quickly arrest the spread of the Ebola 

virus in West Africa and contain the 

disease as quickly as possible. The 

funding will support the impacted 

countries and the surrounding countries 

to combat this health crisis. This 

funding will target the following 

countries: Liberia, Sierra Leone, Guinea, 

Mauritania, Mali, Senegal, Guinea 

Bissau, Ghana, Gambia, Cote d’Ivoire, 

Togo, Benin, and Nigeria to support the 

responses of the CDC to the outbreak of 

Ebola virus in West Africa. This funding 

will enable the U.S. to provide unified 

mobilization to address a crisis of this 

magnitude. CDC will continue to build 

partnerships and strengthen existing 

projects to respond to Ebola. CDC and 

its partners will help to address the 

need for surveillance, detection, 

coordination, response, and increase 

eligible governments’ capacity to 

respond to the Ebola outbreak. 

Award Information: 

Type of Award: Amended FOA. 

Approximate Total Current Fiscal 

Year ACA Funding: $2,000,000. 

Anticipated Number of Awards: 

multiple. 

Fiscal Year Funds: 2015. 

Anticipated Award Date: October 30, 

2014. 

Application Selection Process: 

Funding will be awarded to applicant 

based on results from the technical 

review recommendation. 

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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 63127 

Dated: October 17, 2014. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–25133 Filed 10–17–14; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1027] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Infant Formula 

Recall Regulations 

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 

21, 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 0910–0188. 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. 

Infant Formula Recall Regulations—21 

CFR 107.230, 107.240, 107.250, 107.260, 

and 107.280 (OMB Control Number 

0910–0188)—(Extension) 

Section 412(e) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350a(e)) provides that if the 

manufacturer of an infant formula has 

knowledge that reasonably supports the 

conclusion that an infant formula 

processed by that manufacturer has left 

its control and may not provide the 

nutrients required in section 412(i) of 

the FD&C Act or is otherwise 

adulterated or misbranded, the 

manufacturer must promptly notify the 

Secretary of Health and Human Services 

(the Secretary). If the Secretary 

determines that the infant formula 

presents a risk to human health, the 

manufacturer must immediately take all 

actions necessary to recall shipments of 

such infant formula from all wholesale 

and retail establishments, consistent 

with recall regulations and guidelines 

issued by the Secretary. Section 

412(f)(2) of the FD&C Act states that 

‘‘the Secretary shall by regulation 

prescribe the scope and extent of recalls 

of infant formula necessary and 

appropriate for the degree of risk to 

human health presented by the formula 

subject to recall.’’ Our infant formula 

recall regulations in part 107 (21 CFR 

part 107) implement these statutory 

provisions. 

Section 107.230 requires each 

recalling firm to conduct an infant 

formula recall with the following 

elements: (1) Evaluate the hazard to 

human health, (2) devise a written recall 

strategy, (3) promptly notify each 

affected direct account (customer) about 

the recall, and (4) furnish the 

appropriate FDA district office with 

copies of these documents. If the 

recalled formula presents a risk to 

human health, the recalling firm must 

also request that each establishment that 

sells the recalled formula post (at point 

of purchase) a notice of the recall and 

provide us with a copy of the notice. 

Section 107.240 requires the recalling 

firm to conduct an infant formula recall 

with the following elements: (1) Notify 

the appropriate FDA district office of 

the recall by telephone within 24 hours, 

(2) submit a written report to that office 

within 14 days, and (3) submit a written 

status report at least every 14 days until 

the recall is terminated. Before 

terminating a recall, the recalling firm is 

required to submit a recommendation 

for termination of the recall to the 

appropriate FDA district office and wait 

for our written concurrence (§ 107.250). 

Where the recall strategy or 

implementation is determined to be 

deficient, we may require the firm to 

change the extent of the recall, carry out 

additional effectiveness checks, and 

issue additional notifications 

(§ 107.260). In addition, to facilitate 

location of the product being recalled, 

the recalling firm is required to 

maintain distribution records for at least 

1 year after the expiration of the shelf 

life of the infant formula (§ 107.280). 

The reporting and recordkeeping 

requirements described previously are 

designed to enable us to monitor the 

effectiveness of infant formula recalls in 

order to protect babies from infant 

formula that may be unsafe because of 

contamination or nutritional inadequacy 

or otherwise adulterated or misbranded. 

We use the information collected under 

these regulations to help ensure that 

such products are quickly and 

efficiently removed from the market. 

In the Federal Register of August 7, 

2014 (79 FR 46270), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the annual burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

107.230; elements of infant formula recall ...... 2 1 2 4,450 8,900 

107.240; notification requirements ................... 2 1 2 1,482 2,964 

107.250; termination of infant formula recall ... 2 1 2 120 240 

107.260; revision of an infant formula recall 2 1 1 1 625 625 

Total .......................................................... ............................ ............................ ............................ ............................ 12,729 

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

2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine 

business practice. 

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