52056 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section/activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 2 ............................................................................ ........................ ........................ ........................ ........................ 12,729 

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

2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine 

business practice. 

The reporting and third-party 

disclosure burden estimates are based 

on FDA’s records, which show that 

there are six manufacturers of infant 

formula and that there have been, on 

average, two infant formula recalls per 

year for the past 3 years. Based on this 

information, FDA estimates that there 

will be, on average, approximately two 

infant formula recalls per year over the 

next 3 years. 

Thus, FDA estimates that two 

respondents will conduct recalls 

annually under §§ 107.230, 107.240, and 

107.250. The estimated number of 

respondents for § 107.260 is minimal 

because FDA seldom uses this section; 

therefore, FDA estimates that there will 

be one or fewer respondents annually 

for § 107.260. The estimated number of 

hours per response is an average based 

on FDA’s experience and information 

from firms that have conducted recalls. 

FDA estimates that two respondents 

will conduct infant formula recalls 

under § 107.230 and that it will take a 

respondent 4,450 hours to comply with 

the requirements of that section, for a 

total of 8,900 hours. FDA estimates that 

two respondents will conduct infant 

formula recalls under § 107.240 and that 

it will take a respondent 1,482 hours to 

comply with the requirements of that 

section, for a total of 2,964 hours. FDA 

estimates that two respondents will 

submit recommendations for 

termination of infant formula recalls 

under § 107.250 and that it will take a 

respondent 120 hours to comply with 

the requirements of that section, for a 

total of 240 hours. Finally, FDA 

estimates that one respondent will need 

to carry out additional effectiveness 

checks and issue additional 

notifications, for a total of 625 hours. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. No 

burden has been estimated for the 

recordkeeping requirement in § 107.280 

because these records are maintained as 

a usual and customary part of normal 

business activities. Manufacturers keep 

infant formula distribution records for 

the prescribed period as a matter of 

routine business practice. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

107.230; Elements of an infant formula recall ..................... 2 1 2 50 100 

107.260; Revision of an infant formula recall ...................... 1 1 1 25 25 

Total 2 ............................................................................ ........................ ........................ ........................ ........................ 125 

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

Table 2 reports FDA’s third-party 

disclosure burden estimates for 

§§ 107.230 and 107.260. The estimated 

burden hours per disclosure is an 

average based on FDA’s experience. The 

third-party disclosure burden in 

§ 107.230 is the requirement to 

promptly notify each affected direct 

account (customer) about the recall, and 

if the recalled formula presents a risk to 

human health, the recalling firm must 

also request that each establishment that 

sells the recalled formula post a notice 

of the recall at the point of purchase. 

FDA estimates that two respondents 

will conduct infant formula recalls 

under § 107.230 and that it will take a 

respondent 50 hours to comply with the 

third-party disclosure requirements of 

that section, for a total of 100 hours. The 

third-party disclosure burden in 

§ 107.260 is the requirement to issue 

additional notifications where the recall 

strategy or implementation is 

determined to be deficient. FDA 

estimates that one respondent will issue 

additional notifications under § 107.260 

and that it will take a respondent 25 

hours to comply with the third-party 

disclosure requirements of that section, 

for a total of 25 hours. 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24410 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–2014–N–1414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling Natural Rubber Latex 

Condoms 

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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52057 

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 information 

collection for the labeling of natural 

rubber latex condoms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 8, 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 January 8, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 8, 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– 

2014–N–1414 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Class II 

Special Controls Guidance Document: 

Labeling for Natural Rubber Latex 

Condoms.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Class II Special Controls Guidance 

Document: Labeling for Natural Rubber 

Latex Condoms—21 CFR 884.5300; 

OMB Control Number 0910–0633— 

Extension 

Under the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

class II devices were defined as those 

devices for which there was insufficient 

information to show that general 

controls themselves would provide a 

reasonable assurance of safety and 


sradovich on DSK3GMQ082PROD with NOTICES
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