75564 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

9.2.4.8 Authorized Persons To Pick Up 

Child 

Children may only be released to 

adults authorized by parents or legal 

guardians and whose identity has been 

verified by photo identification. Names, 

addresses, and telephone numbers of 

persons authorized to take a child under 

care out of the facility should be 

obtained during the enrollment process 

and regularly reviewed, along with 

clarification/documentation of any 

custody issues/court orders. The legal 

guardian(s) of the child should be 

established and documented at this 

time. 

9.4.1.12 Record of Valid License, 

Certificate, or Registration of Facility 

Every facility should hold a valid 

license, certificate, or documentation of 

registration prior to operation as 

required by the local and/or state 

statute. 

9.4.2.1 Contents of Child Records 

Programs should maintain a 

confidential file for each child in one 

central location on-site and should be 

immediately available to the child’s 

caregivers/teachers (who should have 

parental/guardian consent for access to 

records), the child’s parents/guardians, 

and the licensing authority upon 

request. The file for each child should 

include the following: 

(a) Pre-admission enrollment 

information; 

(b) Admission agreement signed by 

the parent/guardian at enrollment; 

(c) Initial and updated health care 

assessments, completed and signed by 

the child’s primary care provider, based 

on the child’s most recent well care 

visit; 

(d) Health history completed by the 

parent/guardian at admission; 

(e) Medication record; 

(f) Authorization form for emergency 

medical care; 

(g) Written informed consent forms 

signed by the parent/guardian allowing 

the facility to share the child’s health 

records with other service providers. 

10.4.2.1 Frequency of Inspections for 

Child Care Centers, Large Family Child 

Care Homes, and Small Family Child 

Care Homes 

The licensing inspector or monitoring 

staff should make an onsite inspection 

to measure compliance with licensing/ 

regulatory rules prior to issuing an 

initial license and at least two 

inspections each year to each center and 

large and small family child care home 

thereafter. At least one of the 

inspections should be unannounced, 

and more if they are needed for the 

facility to achieve satisfactory 

compliance or if the facility is closed at 

any time. Sufficient numbers of 

licensing inspectors should be hired to 

provide adequate time visiting and 

inspecting programs to ensure 

compliance with regulations. 

The number of inspections should not 

include those inspections conducted for 

the purpose of investigating complaints. 

Complaints should be investigated 

promptly, based on severity of the 

complaint. States are encouraged to post 

the results of licensing inspections, 

including complaints, on the Internet 

for parent and public review. Parents/

guardians should be provided easy 

access to the licensing rules and made 

aware of how to report complaints to the 

licensing agency. 

Dated: December 12, 2014. 

Linda K. Smith, 

Deputy Assistant Secretary for Early 

Childhood Development, Administration for 

Children and Families, U.S. Department of 

Health and Human Services. 

[FR Doc. 2014–29649 Filed 12–17–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0996] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application Review 

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 January 20, 

2015. 

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 0910–0389. 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. 

Guidance for Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application 

Review—(OMB Control Number 0910– 

0389)—Extension 

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by adding 

section 506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate a 

potential to address an unmet medical 

need. Under section 112(b) of FDAMA, 

FDA issued guidance to industry on fast 

track policies and procedures outlined 

in section 506 of the FD&C Act. The 

guidance discusses collections of 

information that are specified under 

section 506 of the FD&C Act, other 

sections of the Public Health Service 

Act (the PHS Act), or implementing 

regulations. The guidance describes 

three general areas involving the 

collection of information: (1) Fast track 

designation requests, (2) premeeting 

packages, and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and 

premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

Agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it. 

Under section 506(a)(1) of the FD&C 

Act, an applicant who seeks fast track 

designation is required to submit a 

request to the Agency showing that the 

drug product: (1) Is intended for a 

serious or life-threatening condition and 

(2) has the potential to address an 

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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 75565 

unmet medical need. The Agency 

expects that information to support a 

designation request will have been 

gathered under existing provisions of 

the FD&C Act, the PHS Act, or the 

implementing regulations. If such 

information has already been submitted 

to the Agency, the information may be 

summarized in the fast track designation 

request. The guidance recommends that 

a designation request include, where 

applicable, additional information not 

specified elsewhere by statute or 

regulation. For example, additional 

information may be needed to show that 

a product has the potential to address an 

unmet medical need where an approved 

therapy exists for the serious or lifethreatening condition to be treated. 

Such information may include clinical 

data, published reports, summaries of 

data and reports, and a list of references. 

The amount of information and 

discussion in a designation request need 

not be voluminous, but it should be 

sufficient to permit a reviewer to assess 

whether the criteria for fast track 

designation have been met. 

After the Agency makes a fast track 

designation, a sponsor or applicant may 

submit a premeeting package that may 

include additional information 

supporting a request to participate in 

certain fast track programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for fast track designation, the 

Agency expects that most sponsors or 

applicants will have gathered such 

information to meet existing 

requirements under the FD&C Act, the 

PHS Act, or implementing regulations. 

These may include descriptions of 

clinical safety and efficacy trials not 

conducted under an investigational new 

drug application (i.e., foreign studies) 

and information to support a request for 

accelerated approval. If such 

information has already been submitted 

to FDA, the information may be 

summarized in the premeeting package. 

Consequently, FDA anticipates that the 

additional collection of information 

attributed solely to the guidance will be 

minimal. 

Under section 506(c) of the FD&C Act, 

a sponsor must submit sufficient 

clinical data for the Agency to 

determine, after preliminary evaluation, 

that a fast track product may be 

effective. Section 506(c) also requires 

that an applicant provide a schedule for 

the submission of information necessary 

to make the application complete before 

FDA can commence its review. The 

guidance does not provide for any new 

collection of information regarding the 

submission of portions of an application 

that are not required under section 

506(c) of the FD&C Act or any other 

provision of the FD&C Act. 

All forms referred to in the guidance 

have current OMB approval: Forms FDA 

1571 (OMB control number 0910–0014), 

356h (OMB control number 0910–0338), 

and 3397 (OMB control number 0910– 

0297). 

Respondents to this information 

collection are sponsors and applicants 

who seek fast track designation under 

section 506 of the FD&C Act. The 

Agency estimates the total annual 

number of respondents submitting 

requests for fast track designation to the 

Center for Biologics Evaluation and 

Research and the Center for Drug 

Evaluation and Research is 

approximately 81, and the number of 

requests received is approximately 115 

annually. FDA estimates that the 

number of hours needed to prepare a 

request for fast track designation is 

approximately 60 hours per request. 

Not all requests for fast track 

designation may meet the statutory 

standard. Of the requests for fast track 

designation made per year, the Agency 

granted approximately 100 requests 

from 81 respondents, and for each of 

these granted requests a premeeting 

package was submitted to the Agency. 

FDA estimates that the preparation 

hours are approximately 100 hours per 

premeeting package. 

In the Federal Register of August 1, 

2014 (79 FR 44780), 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: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance for industry: Fast track drug development 

programs: Designation, development, and 

application review 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Designation Requests .......................................................... 81 1.42 115 60 6,900 

Premeeting Packages .......................................................... 81 1.09 88 100 8,800 

Total .............................................................................. ........................ ........................ ........................ ........................ 15,700 

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

Dated: December 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29607 Filed 12–17–14; 8:45 am] 

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