28234 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

Compensation Program Act of 2000 (42 

U.S.C. 7384–7385) was enacted. This 

Act established a federal compensation 

program for employees of the 

Department of Energy (DOE) and certain 

of its contractors, subcontractors and 

vendors, who have suffered cancers and 

other designated illnesses as a result of 

exposures sustained in the production 

and testing of nuclear weapons. 

Executive Order 13179, issued on 

December 7, 2000, delegated authorities 

assigned to ‘‘the President’’ under the 

Act to the Departments of Labor, Health 

and Human Services, Energy and 

Justice. The Department of Health and 

Human Services (DHHS) was delegated 

the responsibility of establishing 

methods for estimating radiation doses 

received by eligible claimants with 

cancer applying for compensation. 

NIOSH is applying the following 

methods to estimate the radiation doses 

of individuals applying for 

compensation. 

In performance of its dose 

reconstruction responsibilities, under 

the Act, NIOSH is providing voluntary 

interview opportunities to claimants (or 

their survivors) individually and 

providing them with the opportunity to 

assist NIOSH in documenting the work 

history of the employee by 

characterizing the actual work tasks 

performed. In addition, NIOSH and the 

claimant may identify incidents that 

may have resulted in undocumented 

radiation exposures, characterizing 

radiological protection and monitoring 

practices, and identify co-workers and 

other witnesses as may be necessary to 

confirm undocumented information. In 

this process, NIOSH uses a computer 

assisted telephone interview (CATI) 

system, which allows interviews to be 

conducted more efficiently and quickly 

as opposed to a paper-based interview 

instrument. Both interviews are 

voluntary and failure to participate in 

either or both interviews will not have 

a negative effect on the claim, although 

voluntary participation may assist the 

claimant by adding important 

information that may not be otherwise 

available. 

There are no changes to the questions 

contained in the package, or the 

estimated burden hours. This 

Information Collection Request (ICR) is 

being submitted as a reinstatement 

because the previous ICR expired on 

April 30, 2018 and the updated ICR was 

not submitted before the expiration 

date. NIOSH uses the data collected in 

this process to complete an individual 

dose reconstruction that accounts, as 

fully as possible, for the radiation dose 

incurred by the employee in the line of 

duty for DOE nuclear weapons 

production programs. After dose 

reconstruction, NIOSH also performs a 

brief, voluntary final interview with the 

claimant to explain the results and to 

allow the claimant to confirm or 

question the records NIOSH has 

compiled. This will also be the final 

opportunity for the claimant to 

supplement the dose reconstruction 

record. 

At the conclusion of the dose 

reconstruction process, the claimant 

submits a form to confirm that the 

claimant has no further information to 

provide to NIOSH about the claim at 

this time. The form notifies the claimant 

that signing the form allows NIOSH to 

forward a dose reconstruction report to 

DOL and to the claimant, and closes the 

record on data used for the dose 

reconstruction. Signing this form does 

not indicate that the claimant agrees 

with the outcome of the dose 

reconstruction. The dose reconstruction 

results will be supplied to the claimant 

and to the DOL, the agency that will 

utilize them as one part of its 

determination of whether the claimant 

is eligible for compensation under the 

Act. 

Total annualized burden is estimated 

to be 3900 hours. There is no cost to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Claimant .......................................................... Initial Interview ............................................... 3,600 1 1 

Claimant .......................................................... Conclusion form OCAS–1 .............................. 3,600 1 5/60 

Jeffrey M. Zirger, 

Acting 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. 2018–12972 Filed 6–15–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0286] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Formal Meetings Between the 

Food and Drug Administration and 

Biosimilar Biological Product 

Sponsors or Applicants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (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 formal meetings 

between FDA and biosimilar biological 

product sponsors or applicants. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 17, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 17, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 


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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28235 

at the end of August 17, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2013–D–0286 for ‘‘Guidance for 

Industry: Formal Meetings Between 

Between the FDA and Biosimilar 

Biological Product Sponsors or 

Applicants.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Guidance for Industry: Formal 

Meetings Between the FDA and 

Biosimilar Biological Product Sponsors 

or Applicants 

OMB Control Number 0910–0802— 

Extension 

The Biologics Price Competition and 

Innovation Act of 2009, the Biosimilar 

User Fee Act of 2012, and the recent 

passage of the Biosimilar User Fee 

Amendments of 2017 (BsUFA II) under 

Title IV of the Food and Drug 

Administration Reauthorization Act of 

2017, authorizes user fees for biosimilar 

biological products. FDA has committed 

to meeting certain performance goals in 

connection with the reauthorized 

biosimilar user fee program. FDA 

developed a guidance for industry 

entitled ‘‘Formal Meetings Between 

FDA and Biosimilar Biological Products 

Sponsors or Applicants’’ to provide 

recommendations to industry on formal 

meetings between FDA and sponsors or 

applicants relating to the development 

and review of biosimilar biological 

products regulated by the Center for 

Drug Evaluation and Research (CDER) or 

the Center for Biologics Evaluation and 

Research (CBER) and assist sponsors 

and applicants in generating and 

submitting meeting requests and the 

associated meeting packages to FDA for 

biosimilar biological products. The 

guidance describes FDA’s current 


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28236 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

thinking on how the Agency intends to 

interpret and apply certain provisions of 

BsUFA II and provides information on 

specific performance goals for the 

management of meetings associated 

with the development and review of 

biosimilar biological products. The 

guidance includes two types of 

information collections: (1) The 

submission of a meeting request 

containing certain information and (2) 

the submission of the information 

package(s) that accompany the meeting 

request. This information collection 

supports this Agency guidance 

document. 

A. Request for a Meeting 

Under the guidance, a sponsor or 

applicant interested in meeting with 

CDER or CBER should submit a meeting 

request to the sponsor’s or applicant’s 

application (i.e., investigational new 

drug application, biologics license 

application). If there is no application, 

a sponsor or applicant should submit 

the request to either the appropriate 

CDER division director, with a copy 

sent to the division’s chief of project 

management staff, or to the division 

director of the appropriate product 

office within CBER. However, a sponsor 

or applicant should only submit such a 

request after first contacting the 

appropriate review division or the 

Biosimilars Program staff, CDER, Office 

of New Drugs, to determine to whom the 

request should be directed, how it 

should be submitted, the appropriate 

format for the request, and to arrange for 

confirmation of receipt of the request. 

Under the guidance, FDA requests 

that sponsors and applicants 

incorporate certain information in the 

meeting request including: 

1. Product name, 

2. application number (if applicable), 

3. proposed proper name or proper 

name (post licensure), 

4. structure, 

5. reference product name, 

6. proposed indication(s) or context of 

product development, 

7. meeting type being requested (the 

rationale for requesting the meeting type 

should be included), 

8. a brief statement of the purpose of 

the meeting, including a brief 

background of the issues underlying the 

agenda and, as applicable, a brief 

summary of completed or planned 

studies and clinical trials or data the 

sponsor or applicant intends to discuss 

at the meeting, the general nature of the 

critical questions to be asked, and where 

the meeting fits in the overall 

development plans, 

9. a list of specific objectives/ 

outcomes expected from the meeting, 

10. a proposed agenda, including 

times required for each agenda item, 

11. a list of questions grouped by 

discipline and a brief explanation of the 

context and purpose of each question, 

12. a list of all individuals with their 

titles and affiliations who will attend 

the requested meeting from the 

requestor’s organization and 

consultants, 

13. a list of FDA staff, if known, or 

disciplines asked to participate in the 

requested meeting, 

14. suggested dates and times for the 

meeting, and 

15. the proposed format of the 

meeting (i.e., face to face meeting, 

teleconference, or videoconference). 

This information is be used by FDA 

to facilitate formal meetings with 

biosimilar biological product sponsors. 

B. Information Package 

FDA requests that a sponsor or 

applicant submit a meeting package to 

the appropriate review division with the 

meeting request. FDA recommends that 

the information packages generally 

include: 

1. Product name and application 

number (if applicable), 

2. proposed proper name or proper 

name (post licensure), 

3. structure, 

4. reference product name, 

5. proposed indication(s) or context of 

product development, 

6. dosage form, route of 

administration, dosing regimen 

(frequency and duration), and 

presentation(s), 

7. a list of all sponsor’s or applicant’s 

attendees and consultants with their 

titles and affiliations who will attend 

the requested meeting, 

8. background that includes a brief 

history of the development program and 

the status of product development (e.g., 

chemistry, manufacturing, and controls; 

nonclinical; and clinical, including any 

development outside the United States, 

as applicable), 

9. a brief statement summarizing the 

purpose of the meeting, 

10. the proposed agenda, 

11. a list of questions for discussion 

grouped by discipline and with a brief 

summary for each question to explain 

the need or context for the question, and 

12. data to support discussion of the 

listed questions, organized by discipline 

and question. 

The purpose of the meeting package is 

to provide FDA staff the opportunity to 

adequately prepare for the meeting, 

including the review of relevant data 

concerning the product. 

Description of Respondents: A 

sponsor or applicant for a biosimilar 

biological product who requests a 

formal meeting with FDA regarding the 

development and review of a biosimilar 

biological product. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance for Industry: Formal Meetings Between FDA and 

Biosimilar Biological Product Sponsors or Applicants 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER Meeting Requests ..................................................... 36 2.5 89 15 1,335 

CBER Meeting Requests ..................................................... 2 1 2 15 30 

CDER Information Packages ............................................... 29 2.2 64 30 1,920 

CBER Information Packages ............................................... 2 2 4 30 120 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,405 

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

Since the last OMB approval there has 

been an increase in meeting requests 

with CDER and a corresponding 

increase in the number of information 

packages. Accordingly, we have 

adjusted our estimate of CDER meeting 

requests upward by six respondents. We 

attribute this change to an increase in 

biosimilar product development. 

Dated: June 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12968 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 


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