45290 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

Commission considers your online 

comment, you must file it at https://

ftcpublic.commentworks.com/ftc/ 

BusinessOpportunityRulePRA_by 

following the instructions on the webbased form. When this Notice appears at 

http://www.regulations.gov/#!home, you 

also may file a comment through that 

Web site. 

If you file your comment on paper, 

write ‘‘Business Opportunity Rule 

Paperwork Comment, FTC File No. 

P114408’’ on your comment and on the 

envelope, and mail it to the following 

address: Federal Trade Commission, 

Office of the Secretary, 600 

Pennsylvania Avenue NW., Suite CC– 

5610 (Annex J), Washington, DC 20580, 

or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW., 

5th Floor, Suite 5610, Washington, DC 

20024. If possible, submit your paper 

comment to the Commission by courier 

or overnight service. 

Because your comment will be placed 

on the publicly accessible FTC Web site 

at https://www.ftc.gov/, you are solely 

responsible for making sure that your 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include any sensitive personal 

information, such as your or anyone 

else’s Social Security number; date of 

birth; driver’s license number or other 

state identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure that your 

comment does not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on the public FTC Web 

site—as legally required by FTC Rule 

4.9(b)—we cannot redact or remove 

your comment from the FTC Web site, 

unless you submit a confidentiality 

request that meets the requirements for 

such treatment under FTC Rule 4.9(c), 

and the General Counsel grants that 

request. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before November 27, 2017. For 

information on the Commission’s 

privacy policy, including routine uses 

permitted by the Privacy Act, see 

https://www.ftc.gov/site-information/ 

privacy-policy. 

David C. Shonka, 

Acting General Counsel. 

[FR Doc. 2017–20846 Filed 9–27–17; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No.: 0970—NEW] 

Submission for OMB Review; 

Comment Request; Child Care and 

Development Fund Quality Progress 

Report 

Description: Lead Agencies are 

required to spend a certain percent of 

their Child Care and Development Fund 

(CCDF) awards on activities to improve 

the quality of child care. Lead Agencies 

are also required to invest in at least one 

of 10 allowable quality activities 

included in the Child Care and 

Development Block Grant (CCDBG) Act 

of 2014. In order to ensure that States 

and Territories are meeting these 

requirements, the CCDBG Act and the 

CCDF final rule require Lead Agencies 

to submit an annual report, identified as 

the Quality Progress Report in the CCDF 

final rule. The report must describe how 

quality funds were expended, including 

what types of activities were funded and 

measures used to evaluate progress in 

improving the quality of child care 

programs and services. The QPR 

replaces the Quality Performance Report 

that was previously an appendix to the 

CCDF Plan. The QPR increased 

transparency on quality spending and 

will continue to gather detailed 

information on how States and 

Territories are spending their quality 

funds, as well as more specific data 

points to reflect the requirements in the 

CCDBG Act and the CCDF final rule. 

In the QPR, Lead Agencies are asked 

about the State’s or Territory’s progress 

in meeting its goals as reported in the 

CCDF Plan, and provide available data 

on the results of those activities. 

Specifically, this report will: (1) Ensure 

accountability for the use of CCDF 

quality funds, including a set-aside for 

quality infant and toddler care that 

begins in FY 2017; (2) track progress 

toward meeting State- and Territory-set 

indicators and benchmarks for 

improvement of child care quality per 

what they described in their CCDF 

Plans; (3) summarize how the Lead 

Agency is building a progression of 

professional development for child care 

providers as envisioned in the CCDBG 

Act of 2014 and CCDF final rule; and (4) 

inform federal technical assistance 

efforts and decisions regarding strategic 

use of quality funds. 

The Office of Child Care (OCC) has 

given thoughtful consideration to the 

comments received during the 60-day 

Public Comment Period and has revised 

the QPR to better align with the new 

program requirements made under the 

CCDBG Act of 2014 and the final rule. 

The revised document also contains 

additional guidance and clarification 

where appropriate in order to improve 

the quality of information that is being 

collected. Note: A correction was also 

made to the burden hours. This 30-day 

Public Comment Period provides an 

opportunity for the public to submit 

comments to the Office of Management 

and Budget (OMB). 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 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. 

Respondents: State and Territory 

CCDF Lead Agencies (56). 

Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45291 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

CCDF QPR ...................................................................................................... 56 1 60.0 3,360 

Estimated Total Annual Burden 

Hours: 3,360 hours. 

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, 330 

C Street SW., Washington, DC 20201. 

Attention 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. 2017–20765 Filed 9–27–17; 8:45 am] 

BILLING CODE 4184–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Fee for Using a Rare Pediatric Disease 

Priority Review Voucher in Fiscal Year 

2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the fee rate for using a rare 

pediatric disease priority review 

voucher for fiscal year (FY) 2018. The 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), as amended by the Food 

and Drug Administration Safety and 

Innovation Act (FDASIA), authorizes 

FDA to determine and collect rare 

pediatric disease priority review user 

fees for certain applications for review 

of human drug or biological products 

when those applications use a rare 

pediatric disease priority review 

voucher. These vouchers are awarded to 

the sponsors of rare pediatric disease 

product applications that meet all of the 

requirements of this program and that 

are submitted 90 days or more after July 

9, 2012, upon FDA approval of such 

applications. The amount of the fee for 

using a rare pediatric disease priority 

review voucher is determined each FY, 

based on the difference between the 

average cost incurred by FDA in the 

review of a human drug application 

subject to priority review in the 

previous FY and the average cost 

incurred in the review of an application 

that is not subject to priority review in 

the previous FY. This notice establishes 

the rare pediatric disease priority review 

fee rate for FY 2018 and outlines the 

payment procedures for such fees. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. Marcarelli, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202F, Silver Spring, MD 

20993–0002, 301–796–7223. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 908 of FDASIA (Pub. L. 112– 

144) added section 529 to the FD&C Act 

(21 U.S.C. 360ff). In section 529 of the 

FD&C Act, Congress encouraged 

development of new human drugs and 

biological products for prevention and 

treatment of certain rare pediatric 

diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 529 of 

the FD&C Act, the sponsor of an eligible 

human drug application submitted 90 

days or more after July 9, 2012, for a rare 

pediatric disease (as defined in section 

529(a)(3)) shall receive a priority review 

voucher upon approval of the rare 

pediatric disease product application. 

The recipient of a rare pediatric disease 

priority review voucher may either use 

the voucher for a future human drug 

application submitted to FDA under 

section 505(b)(1) of the FD&C Act (21 

U.S.C. 355(b)(1)) or section 351(a) of the 

Public Health Service Act (42 U.S.C. 

262(a)), or transfer (including by sale) 

the voucher to another party. The 

voucher may be transferred (including 

by sale) repeatedly until it ultimately is 

used for a human drug application 

submitted to FDA under section 

505(b)(1) of the FD&C Act or section 

351(a) of the Public Health Service Act. 

A priority review is a review conducted 

with a Prescription Drug User Fee Act 

(PDUFA) goal date of 6 months after the 

receipt or filing date, depending on the 

type of application. Information 

regarding PDUFA goals is available at 

http://www.fda.gov/downloads/ 

forindustry/userfees/prescriptiondrug

userfee/ucm511438.pdf. 

The applicant that uses a rare 

pediatric disease priority review 

voucher is entitled to a priority review 

of its eligible human drug application, 

but must pay FDA a rare pediatric 

disease priority review user fee in 

addition to any user fee required by 

PDUFA for the application. Information 

regarding the rare pediatric disease 

priority review voucher program is 

available at: http://www.fda.gov/Drugs/ 

DevelopmentApprovalProcess/ 

DevelopmentResources/ 

ucm375479.htm. 

This notice establishes the rare 

pediatric disease priority review fee rate 

for FY 2018 at $2,830,579 and outlines 

FDA’s procedures for payment of rare 

pediatric disease priority review user 

fees. This rate is effective on October 1, 

2017, and will remain in effect through 

September 30, 2018. 

II. Rare Pediatric Priority Review User 

Fee for FY 2018 

Under section 529(c)(2) of the FD&C 

Act, the amount of the rare pediatric 

disease priority review user fee is 

determined each fiscal year based on the 

difference between the average cost 

incurred by FDA in the review of a 

human drug application subject to 

priority review in the previous fiscal 

year, and the average cost incurred by 

FDA in the review of a human drug 

application that is not subject to priority 

review in the previous fiscal year. 

A priority review is a review 

conducted with a PDUFA goal date of 6 

months after the receipt or filing date, 

depending on the type of application. 

Under the PDUFA goals letter, FDA has 

committed to reviewing and acting on 

90 percent of the applications granted