Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51847 

designation and provides examples of 

surrogate endpoints and intermediate 

clinical endpoints used to support 

accelerated approval. 

The information collection resulting 

from requests for priority review 

designation and breakthrough therapy 

designation is set forth in rows 1 and 2 

of table 1 and is approved by the Office 

of Management and Budget (OMB) 

under control number 0910–0765. The 

information collection resulting from 

requests for accelerated approval is 

approved by OMB under control 

numbers 0910–0001 and 0910–0338. 

The provisions of the guidance 

relating to fast track development and 

other issues such as serious condition 

and unmet medical need replace the 

guidance entitled ‘‘Fast Track Drug 

Development Programs—Designation, 

Development, and Application Review.’’ 

Consequently, the information 

collection resulting from the guidance 

‘‘Fast Track Drug Development 

Programs—Designation, Development, 

and Application Review’’ (OMB control 

number 0910–0389) is now being 

incorporated into OMB control number 

0910–0765 (guidance for industry 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’). 

A sponsor or 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 

unmet medical need. The Agency 

expects that most information to 

support a designation request will have 

been gathered under existing 

requirements for preparing an 

investigational new drug (IND), new 

drug application (NDA), or biologic 

license application (BLA). If such 

information has already been submitted 

to the Agency, the information may be 

summarized in the fast track designation 

request. A designation request should 

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 life-threatening 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 for preparing an IND, 

NDA, or BLA. These may include 

descriptions of clinical safety and 

efficacy trials not conducted under an 

IND (e.g., 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. 

The Agency estimates the total annual 

number of respondents submitting 

requests for fast track designation is 

approximately 140, and the number of 

requests received is approximately 187 

annually. FDA estimates that the 

number of hours needed to prepare a 

request for fast track designation is 

approximately 60 hours per request 

(row 3 in table 1). 

Of the requests for fast track 

designation made per year, the Agency 

granted approximately 132 requests 

from 107 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 (row 4 in table 1). 

The guidance also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

202.1 and 21 CFR parts 314, and 601, 

and sections 505(a), 506(a)(1), 735, and 

736 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(a), 

356(a)(1), 379(g), and 379(h)) have been 

approved under OMB control numbers 

0910–0686, 0910–0001, 0910–0338, 

0910–0014, and 0910–0297. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance for Industry: Expedited Programs for Serious 

Conditions—Drugs and Biologics 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Priority review designation request ...................................... 48 1.7 82 30 2,400 

Breakthrough therapy designation request .......................... 87 1.29 113 70 7,910 

Fast track designation request ............................................ 140 1.33 187 60 11,220 

Fast track premeeting packages ......................................... 107 1.23 132 100 13,200 

Total .............................................................................. ........................ ........................ ........................ ........................ 34,730 

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

The data pertaining to fast track 

designation (last two rows of table 1) 

has changed since the last OMB 

approval. 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24296 Filed 11–7–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6100] 

Intent To Review an Analysis Data 

Reviewer’s Guide; Notice of 

Availability, Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for Drug 

Evaluation and Research (CDER), is 

establishing a public docket to collect 

comments related to a proposed 

Analysis Data Reviewer’s Guide (ADRG) 

template. As part of FDA’s ongoing 

collaboration with the Pharmaceutical 

Users Software Exchange (PhUSE), an 


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51848 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 

independent, non-profit consortium 

addressing computational science 

issues, a PhUSE working group 

developed the PhUSE ADRG template. 

The purpose of this review is to evaluate 

the template and determine whether 

FDA will recommend its use either as is, 

or in a modified form, for regulatory 

submissions of study data. FDA is 

seeking public comment on the use of 

the PhUSE ADRG template for 

regulatory submissions. 

DATES: Although you can comment on 

the PhUSE ADRG template at any time, 

to ensure that the Agency considers 

your comments in this review, please 

submit either electronic or written 

comments by January 8, 2018. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6100 for ‘‘Intent to Review an 

Analysis Data Reviewer’s Guide 

Template.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Crystal Allard, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 1518, 

Silver Spring, MD 20993–0002, 301– 

796–8856, crystal.allard@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is a participating member of 

PhUSE, an independent, non-profit 

consortium of academic, regulatory, 

non-profit, and private sector entities. 

PhUSE provides a global platform for 

the discussion of topics encompassing 

the work of biostatisticians, data 

managers, statistical programmers, and 

e-clinical information technology 

professionals, with the mission of 

providing an open, transparent, and 

collaborative forum to address 

computational science issues. As part of 

this collaboration, PhUSE working 

groups develop and periodically publish 

proposals for enhancing the review and 

analysis of human and animal study 

data submitted to regulatory agencies. 

You can learn more about PhUSE 

working groups at http://www.phuse.eu/ 

cs-working-groups.aspx. (FDA has 

verified the Web site addresses as of the 

date this document publishes in the 

Federal Register, but Web sites are 

subject to change over time.) 

In December 2014, FDA published the 

Study Data Technical Conformance 

Guide (the Guide, available at https://

www.fda.gov/ForIndustry/ 

DataStandards/StudyDataStandards/ 

default.htm), which contains technical 

recommendations to sponsors for the 

submission of animal and human study 

data and related information in a 

standardized electronic format. In 

section 2.3 of the Guide, FDA 

recommends that sponsors should 

include a plan (e.g., in the New Drug 

Application (NDA)) describing the 

submission of standardized study data 

to FDA. The FDA’s Analysis Data 

Resources Web page provides 

recommendations for preparing an 

ADRG. 

FDA now intends to review the 

PhUSE ADRG template, a deliverable of 

the working group effort described 

previously in this document, with the 

potential result that FDA could 

recommend the use of the template in 

its current form, or in a modified form, 

for use in the regulatory submission of 

study data in conformance with the 

Guide. FDA invites public comment on 

all matters regarding the use of the 

PhUSE ADRG template. 

II. Electronic Access 

The PhUSE ADRG template is 

available at: http://www.phusewiki.org/ 

wiki/index.php?title=Analysis_Data_

Reviewer%27s_Guide. 

Dated: November 1, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24237 Filed 11–7–17; 8:45 am] 

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