Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42127 

Ave., Bldg. 66, Rm. G642, Silver Spring, 

MD 20993–0002, Aden.Asefa@

fda.hhs.gov, 301–796–0400, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced Advisory Committee 

meeting cannot always be published 

quickly enough to provide timely 

notice. Therefore, you should always 

check the Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On September 27, 2018, the 

Committee will discuss, make 

recommendations, and vote on the 

premarket approval application 

sponsored by Sequent Medical, Inc. for 

the Woven Endobridge (WEB) 

Aneurysm Embolization System, which 

is intended to treat wide-neck 

intracranial aneurysms arising or 

located at a vessel bifurcation. The WEB 

device is being evaluated in the WEB 

Intrasaccular Therapy Study (WEB–IT): 

a multicenter, prospective, nonrandomized investigation. The 

Committee will be asked to review the 

clinical data from the WEB–IT study to 

help the Agency assess the safety and 

effectiveness of the device for the 

proposed indications for use. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate Advisory Committee 

meeting link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before September 20, 2018. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

September 12, 2018. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 13, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallett 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17867 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0248] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution; Appeals Above the 

Division Level 

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 the process for 

formally resolving scientific and 

procedural disputes in the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER) that cannot be 

resolved at the division level. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 19, 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 October 19, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 19, 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’’). 


daltland on DSKBBV9HB2PROD with NOTICES
42128 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

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– 

2012–N–0248 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Formal Dispute 

Resolution; Appeals Above the Division 

Level.’’ 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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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 on Formal 

Dispute Resolution; Appeals Above the 

Division Level 

OMB Control Number 0910–0430— 

Extension 

This information collection approval 

request is for FDA guidance on the 

process for formally resolving scientific 

and procedural disputes in FDA’s CDER 

and CBER that cannot be resolved at the 

division level. The guidance document 

describes procedures for formally 

appealing such disputes to the office or 

center level and for submitting 

information to assist center officials in 

resolving the issue or issues presented. 

The guidance document provides 

information on how the Agency will 

interpret and apply provisions of the 

existing regulations regarding internal 

Agency review of decisions (§ 10.75 (21 

CFR 10.75)) and dispute resolution 

during the investigational new drug 

(IND) process (§ 312.48 (21 CFR 312.48)) 

and the new drug application/ 

abbreviated new drug application 

(NDA/ANDA) process (§ 314.103 (21 

CFR 314.103)). In addition, the guidance 

document provides information on how 

the Agency will interpret and apply the 

specific Prescription Drug User Fee Act 

(PDUFA) goals for major dispute 

resolution associated with the 

development and review of PDUFA 

products. 

Existing regulations, which appear 

primarily in parts 10, 312, and 314 (21 

CFR parts 10, 312, and 314), establish 

procedures for the resolution of 

scientific and procedural disputes 

between interested persons and the 

Agency, CDER, and CBER. All Agency 

decisions on such matters are based on 

information in the administrative file 

(§ 10.75(d)). In general, the information 

in an administrative file is collected 

under existing regulations in part 312 

(OMB control number 0910–0014), part 

314 (OMB control number 0910–0001), 

and part 601 (21 CFR part 601) (OMB 

control number 0910–0338), which 

specify the information manufacturers 

must submit so that FDA may properly 

evaluate the safety and effectiveness of 

drugs and biological products. This 

information is usually submitted as part 

of an IND, NDA, or biologics license 

application (BLA), or as a supplement to 

an approved application. Although FDA 

already possesses in the administrative 

file the information that would form the 

basis of a decision on a matter in 

dispute resolution, the submission of 

information regarding the request itself 

and the data and information that the 

requestor relies on in the appeal would 

facilitate timely resolution of the 

dispute. The guidance document 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42129 

describes the following collections of 

information not expressly specified 

under existing regulations: The 

submission of the request for dispute 

resolution as an amendment to the 

application for the underlying product, 

including the submission of supporting 

information with the request for dispute 

resolution. 

Agency regulations ((§§ 312.23(a)(11) 

and (d) (21 CFR 312.23(a)(11) and (d), 

314.50 (21 CFR 314.50), 314.94 (21 CFR 

314.94), and 601.2 (21 CFR 601.2)) state 

that information provided to the Agency 

as part of an IND, NDA, ANDA, or BLA 

must be submitted in triplicate and with 

an appropriate cover form. Form FDA 

1571 must accompany submissions 

under INDs and Form FDA 356h must 

accompany submissions under NDAs, 

ANDAs, and BLAs. Both forms have 

valid OMB control numbers as follows: 

Form FDA 1571 (OMB control number 

0910–0014) and Form FDA 356h (OMB 

control number 0910–0338). 

In the guidance document, CDER and 

CBER ask that a request for formal 

dispute resolution be submitted as an 

amendment to the application for the 

underlying product and that it be 

submitted to the Agency in triplicate 

with the appropriate form attached, 

either Form FDA 1571 or Form FDA 

356h. The Agency recommends that a 

request be submitted as an amendment 

in this manner for two reasons: (1) To 

ensure that each request is kept in the 

administrative file with the entire 

underlying application; and (2) to 

ensure that pertinent information about 

the request is entered into the 

appropriate tracking databases. Use of 

the information in the Agency’s tracking 

databases enables the appropriate 

Agency official to monitor progress on 

the resolution of the dispute and to 

ensure that appropriate steps will be 

taken in a timely manner. 

CDER and CBER have determined and 

the guidance document recommends 

that the following information should be 

submitted to the appropriate center with 

each request for dispute resolution so 

that the center may quickly and 

efficiently respond to the request: (1) A 

brief but comprehensive statement of 

each issue to be resolved, including a 

description of the issue, the nature of 

the issue (i.e., scientific, procedural, or 

both), possible solutions based on 

information in the administrative file, 

whether informal dispute resolution 

was sought prior to the formal appeal, 

whether advisory committee review is 

sought, and the expected outcome; (2) a 

statement identifying the review 

division/office that issued the original 

decision on the matter and, if 

applicable, the last Agency official that 

attempted to formally resolve the 

matter; (3) a list of documents in the 

administrative file or additional copies 

of such documents that are deemed 

necessary for resolution of the issue or 

issues; and (4) a statement that the 

previous supervisory level has already 

had the opportunity to review all of the 

material relied on for dispute resolution. 

The information the Agency suggests 

submitting with a formal request for 

dispute resolution consists of: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute; (2) brief statements describing 

the history of the matter; and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the Agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the Agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance document will be minimal. 

Provided in this document is an 

estimate of the annual reporting burden 

for requests for dispute resolution. 

Based on data collected from review 

divisions and offices within CDER and 

CBER, FDA estimates that 

approximately 12 sponsors and 

applicants (respondents) will submit 

requests for formal dispute resolution to 

CDER annually and approximately one 

respondent will submit requests for 

formal dispute resolution to CBER 

annually. 

The total annual responses are the 

total number of requests submitted to 

CDER and CBER in 1 year, including 

requests for dispute resolution that a 

single respondent submits more than 

one time. FDA estimates that CDER 

receives approximately 17 requests 

annually and CBER receives 

approximately 1 request annually. The 

hours per response is the estimated 

number of hours that a respondent 

would spend preparing the information 

to be submitted with a request for 

formal dispute resolution in accordance 

with the guidance document, including 

the time it takes to gather and copy brief 

statements describing the issue from the 

perspective of the person with the 

dispute, brief statements describing the 

history of the matter, and supporting 

information that has already been 

submitted to the Agency. Based on 

experience, FDA estimates that 

approximately 8 hours, on average, 

would be needed per response. 

Therefore, FDA estimates that 8 hours 

will be spent per year by respondents 

requesting formal dispute resolution in 

accordance with the guidance 

document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Requests for formal dispute resolution Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER ................................................................................... 12 1.42 17 8 136 

CBER ................................................................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 144 

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


daltland on DSKBBV9HB2PROD with NOTICES
42130 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

The burden for this information 

collection has changed since the last 

OMB approval. Our burden estimate 

reflects a decrease in burden by 14 

records and 112 hours. We attribute this 

adjustment to a decrease in the number 

of requests received over the last few 

years. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3038] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Request for 

Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 September 

19, 2018. 

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 0910–0206. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Request for Samples and Protocols 

OMB Control Number 0910–0206— 

Extension 

This information collection supports 

Agency regulations. Under section 351 

of the Public Health Service Act (42 

U.S.C. 262), FDA has the responsibility 

to issue regulations that prescribe 

standards designed to ensure the safety, 

purity, and potency of biological 

products and to ensure that the 

biologics licenses for such products are 

only issued when a product meets the 

prescribed standards. Under § 610.2 (21 

CFR 610.2), the Center for Biologics 

Evaluation and Research (CBER) or the 

Center for Drug Evaluation and Research 

may at any time require manufacturers 

of licensed biological products to 

submit to FDA samples of any lot along 

with the protocols showing the results 

of applicable tests prior to distributing 

the lot of the product. In addition to 

§ 610.2, there are other regulations that 

require the submission of samples and 

protocols for specific licensed biological 

products: 21 CFR 660.6 (Antibody to 

Hepatitis B Surface Antigen); 21 CFR 

660.36 (Reagent Red Blood Cells); and 

21 CFR 660.46 (Hepatitis B Surface 

Antigen). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

or manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of the product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 79 

manufacturers submitted samples and 


daltland on DSKBBV9HB2PROD with NOTICES