52058 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

effectiveness but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. 

Condoms without spermicidal 

lubricant containing nonoxynol 9 are 

classified in class II. They were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), which broadened the 

definition of class II devices and now 

permit FDA to establish special controls 

beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000, Congress enacted 

Public Law 106–554, which directed 

FDA to ‘‘reexamine existing condom 

labels’’ and ‘‘determine whether the 

labels are medically accurate regarding 

the overall effectiveness or lack of 

effectiveness in preventing sexually 

transmitted diseases. . . .’’ In response, 

FDA recommended labeling intended to 

provide important information for 

condom users, including the extent of 

protection provided by condoms against 

various types of sexually transmitted 

diseases. 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex without spermicidal 

lubricant. FDA expects approximately 

five new manufacturers or repackagers 

to enter the market yearly and to 

collectively have a third-party 

disclosure burden of 60 hours. The 

number of respondents cited in table 1 

is based on FDA’s database of premarket 

submissions and the electronic 

registration and listing database. The 

average burden per disclosure was 

derived from a study performed for FDA 

by Eastern Research Group, Inc., an 

economic consulting firm, to estimate 

the impact of the 1999 over-the-counter 

(OTC) human drug labeling 

requirements final rule (64 FR 13254, 

March 17, 1999). Because the packaging 

requirements for condoms are similar to 

those of many OTC drugs, we believe 

the burden to design the labeling for 

OTC drugs is an appropriate proxy for 

the estimated burden to design condom 

labeling. 

The special controls guidance 

document also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 807 subpart E have been approved 

under OMB control number 0910–0120; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

The collection of information under 

21 CFR 801.437 does not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995. 

Rather, it is a ‘‘public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Class II Special Controls Guidance Document: Labeling 

for Natural Rubber Latex Condoms Classified Under 21 

CFR 884.5300 .................................................................. 5 1 5 12 60 

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

The estimated burden of this 

information collection has not changed 

since the last OMB approval. 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24415 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6231] 

Use of a Drug Master File for Shared 

System Risk Evaluation and Mitigation 

Strategy Submissions; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Use of a 

Drug Master File for Shared System 

REMS Submissions.’’ The draft 

guidance provides information to 

applicants who are part of a shared 

system Risk Evaluation and Mitigation 

Strategy (REMS) on using an electronic 

Type V Drug Master File (DMF). FDA 

recommends that applicants who are 

part of a shared system REMS use a 

Type V DMF for their REMS 

submissions to improve the efficiency of 

the submission and review process. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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’’). 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52059 

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–6231 for ‘‘Use of a Drug Master 

File for Shared System REMS 

Submissions; Draft Guidance for 

Industry; Availability.’’ 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Gita 

Toyserkani, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2422, Silver Spring, 

MD 20993–0002, 301–796–1783, 

Gita.Toyserkani@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Use a of Drug Master File for Shared 

System REMS Submissions.’’ 

A REMS is a required risk 

management plan that uses tools beyond 

the FDA-approved prescribing 

information to ensure that the benefits 

of certain drugs outweigh their risks (see 

section 505–1 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355–1)). FDA can, under certain 

circumstances, require that the REMS 

for a drug include one or more elements 

to assure safe use (ETASU) (see section 

505–1(f) of the FD&C Act). When 

ETASUs are required for an innovator 

drug, any abbreviated new drug 

application (ANDA) referencing that 

innovator drug must use an shared 

system REMS with the innovator (unless 

FDA waives the requirement for using a 

shared system) (see section 505–1(i) of 

the FD&C Act). There are also 

circumstances under which multiple 

applicants form an SSR to minimize the 

burden on the health care delivery 

system, such as for a class of similar 

products. 

Under a shared system REMS, 

multiple applicants should coordinate 

the submission of identical documents 

to their respective applications. To 

improve the efficiency of the 

submission and review process for 

shared system REMS, FDA recommends 

that applicants who are part of a shared 

system REMS use a Type V DMF for 

their REMS submissions. A DMF is a 

submission to the Agency that may be 

used to provide confidential detailed 

information to the Agency. Among other 

things, a DMF allows the DMF holder to 

authorize other applicants to reference 

information in the holder’s DMF. A 

DMF is submitted solely at the 

discretion of the DMF holder, and the 

technical contents of a DMF are 

customarily reviewed by FDA only in 

connection with the review of an 

application. 

The use of a DMF is not a requirement 

for shared system REMS. However, if 

shared system REMS applicants choose 

to use the DMF option for their shared 

system REMS submissions, this 

guidance (and the technical 

conformance guide that supplements it, 

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

developmentapprovalprocess/forms

submissionrequirements/electronic

submissions/ucm535180.htm) is 

intended to provide an overview of the 

approach for doing so. Also, if shared 

system REMS applicants choose to use 

the DMF option, as of the date specified 

by FDA, they must submit the DMF in 

the Electronic Common Technical 

Document format, as previously stated 

in the guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Certain Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications (Revision 4)’’ (available at 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on use of a DMF for submission of 

shared system REMS. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 


sradovich on DSK3GMQ082PROD with NOTICES
52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 314.50 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR 314.70 have been 

approved under OMB control number 

0910–0001; the collections of 

information in 21 CFR 201.57 have been 

approved under OMB control number 

0910–0572; the collections of 

information in 21 CFR 314.420 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: November 2, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6358] 

Blood Products Advisory Committee 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Blood Products Advisory 

Committee (the Committee). The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues 

related to blood and products derived 

from blood. The meeting will be open to 

the public. 

DATES: The meeting will be held on 

November 30, 2017, from 8 a.m. to 5:45 

p.m. and on December 1, 2017, from 8 

a.m. to 3:30 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD, 20993– 

0002. Answers to commonly asked 

questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Emery or Joanne Lipkind, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993–0002, Bldg. 71, Rm. 6132, at 

240–402–8054, bryan.emery@

fda.hhs.gov and 240–402–8106, 

joanne.lipkind@fda.hhs.gov 

respectively, 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 Web site 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. For those unable to attend in 

person, the meeting will also be 

available via Webcast. The Webcast will 

be available at the following link for 

both days: https://collaboration.fda.gov/ 

bpac2017. 

SUPPLEMENTARY INFORMATION: 

Agenda: On November 30, 2017, the 

Committee members will meet in open 

session to discuss bacterial risk control 

strategies for blood collection 

establishments and transfusion services 

to enhance the safety and availability of 

platelets for transfusion. In the 

afternoon, the Committee will be seated 

as a device classification panel. In open 

session, the panel will discuss the 

appropriate device classification of 

human leukocyte antigen, human 

platelet antigen, and human neutrophil 

antigen devices. On December 1, 2017, 

the committee members will meet in 

open session to discuss strategies to 

reduce the risk of transfusiontransmitted Zika virus. In the afternoon, 

an information session on the 

Transfusion Transmissible Infections 

Monitoring System will be presented to 

the Committee. Finally, the Committee 

will hear an update presentation on the 

April 6, 2017, FDA public workshop on 

emerging tick-borne diseases and blood 

safety. 

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 Web site 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 Web site 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 November 22, 2017. 

Oral presentations from the public will 

be scheduled between approximately 

11:35 a.m. to 12:20 p.m. and 4:15 p.m. 

to 4:45 p.m. on November 30, 2017. Oral 

presentations from the public will also 

be scheduled between approximately 

10:45 a.m. and 11:30 a.m. and 3 p.m. to 

3:30 p.m. on December 1, 2017. 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 November 14, 2017. 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 

November 15, 2017. 

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 Bryan Emery 

or Joanne Lipkind at least 7 days in 

advance of the meeting. 


sradovich on DSK3GMQ082PROD with NOTICES