48096 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

chemical residues (within the former 

tolerance) after the tolerance for the 

pesticide chemical has been revoked, 

suspended, or modified will be able to 

demonstrate that such food was 

handled, e.g., packed or processed, 

during the acceptable timeframes cited 

in the guidance by providing 

appropriate documentation to FDA as 

discussed in the guidance document. 

We are not suggesting that firms 

maintain an inflexible set of documents 

where anything less or different would 

likely be considered unacceptable. 

Rather, we are leaving it to each firm’s 

discretion to maintain appropriate 

documentation to demonstrate that the 

food was so handled during the 

acceptable timeframes. 

Examples of documentation that we 

anticipate will serve this purpose 

consist of documentation associated 

with packing codes, batch records, and 

inventory records. These are types of 

documents that many food processors 

routinely generate as part of their basic 

food production operations. 

Accordingly, under the PRA, we are 

requesting the extension of OMB 

approval for the information collection 

provisions in the guidance. 

Description of Respondents: The 

likely respondents to this collection of 

information are firms in the produce 

and food processing industries that 

handle food products that may contain 

residues of pesticide chemicals after the 

tolerances for the pesticide chemicals 

have been revoked, suspended, or 

modified. 

In the Federal Register of May 25, 

2017 (82 FR 24133), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. One comment 

was posted to the docket but did not 

address any of the four information 

collection topics solicited in our notice 

and so it is not discussed here. 

We therefore estimate the burden of 

this collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of documentation .............................................. 1 1 1 3 3 

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

We expect the total number of 

pesticide tolerances that are revoked, 

suspended, or modified by EPA under 

dietary risk considerations in the next 3 

years to remain at a low level, as there 

have been no changes to the safety 

standard for pesticide residues in food 

since 1996. Thus, we expect the number 

of submissions we will receive under 

the guidance document will also remain 

at a low level. However, to avoid 

counting this burden as zero, we have 

estimated the burden at one respondent 

making one submission a year for a total 

of one annual submission. 

We base our estimate of the hours per 

response on the assumption that the 

information requested in the guidance is 

readily available to the submitter. We 

expect that the submitter will need to 

gather information from appropriate 

persons in the submitter’s company and 

to prepare this information for 

submission to FDA. The submitter will 

almost always merely need to copy 

existing documentation. We believe that 

this effort should take no longer than 3 

hours per submission. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records 

per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Develop documentation process ......................................... 1 1 1 16 16 

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

In determining the estimated annual 

recordkeeping burden, we believe that 

at least 90 percent of firms maintain 

documentation, such as packing codes, 

batch records, and inventory records, as 

part of their basic food production or 

import operations. Therefore, the 

recordkeeping burden was calculated as 

the time required for the 10 percent of 

firms that may not be currently 

maintaining this documentation to 

develop and maintain documentation, 

such as batch records and inventory 

records. In previous information 

collection requests, this recordkeeping 

burden was estimated to be 16 hours per 

record. We retain our prior estimate of 

16 hours per record for the 

recordkeeping burden. As shown in 

table 1 of this document, we estimate 

that one respondent will make one 

submission per year. Although we 

estimate that only 1 out of 10 firms will 

not be currently maintaining the 

necessary documentation, to avoid 

counting the recordkeeping burden for 

the 1 submission per year as 1⁄10 of a 

recordkeeper, we estimate that 1 

recordkeeper will take 16 hours to 

develop and maintain documentation 

recommended by the guidance. 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22285 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2017–N–4951] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

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 


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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48097 

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 information 

collection requirements for 

humanitarian use devices (HUDs). 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 15, 2017. 

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 December 15, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 15, 2017. 

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 2017– 

N–4951 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Devices; Humanitarian Use Devices.’’ 

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 Office 

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. 

Medical Devices; Humanitarian Use 

Devices—21 CFR 814 

OMB Control Number 0910–0332— 

Extension 

This collection of information 

implements the HUDs provision of 

section 520(m) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360j(m)) and part 814, 

subpart H (21 CFR part 814, subpart H). 

Under section 520(m) of the FD&C Act, 

FDA is authorized to exempt an HUD 

from the effectiveness requirements of 


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48098 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

sections 514 and 515 of the FD&C Act 

(21 U.S.C. 360d and 360e) provided that 

the device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risks and benefits 

of currently available devices or 

alternative forms of treatment. 

Respondents may submit a 

humanitarian device exemption (HDE) 

application seeking exemption from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act as 

authorized by section 520(m)(2). The 

information collected will assist FDA in 

making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

whether to exempt an HUD from the 

effectiveness requirements under 

sections 514 and 515 of the FD&C Act, 

provided that the device meets 

requirements set forth under section 

520(m) of the FD&C Act; and (3) 

whether to grant marketing approval(s) 

for the HUD. Failure to collect this 

information would prevent FDA from 

making a determination on the factors 

listed previously in this document. 

Further, the collected information 

would also enable FDA to determine 

whether the holder of an HUD is in 

compliance with the HUD provisions 

under section 520(m) of the FD&C Act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................. 19 1 19 40 760 

HDE Application—814.104 .................................................. 3 1 3 320 960 

HDE Amendments and resubmitted HDEs—814.106 ......... 6 5 30 50 1,500 

HDE Supplements—814.108 ............................................... 110 1 110 80 8,800 

Notification of withdrawal of an HDE—814.116(e)(3) ......... 1 1 1 1 1 

Notification of withdrawal of Institutional Review Board approval—814.124(b) ........................................................... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,223 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeping 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification of emergency use—814.124(a) ........................ 22 1 22 1 22 

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

The number of respondents in tables 

1, 2, and 3 of this document are an 

average based on data for the previous 

3 years, i.e., fiscal years 2014 through 

2016. The number of annual reports 

submitted under § 814.126(b)(1) in table 

1 reflects 35 respondents with approved 

HUD applications. Under 

§ 814.126(b)(2) in table 2, the estimated 

number of recordkeepers is 247. 

The number of respondents has been 

adjusted to reflect updated respondent 

data. This has resulted in an overall 

decrease of 2,971 hours to the total 

estimated annual reporting burden. 

There have been no program changes 

and the estimated Average Burden per 

Response has not changed for any of the 

information collections since the last 

OMB approval. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22320 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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