82 FR 48096 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 198 (October 16, 2017)

Page Range		48096-48098
FR Document		2017-22320

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 information collection requirements for humanitarian use devices (HUDs).

Federal Register, Volume 82 Issue 198 (Monday, October 16, 2017)

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48096-48098]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22320]


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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

[[Page 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.thefederalregister.org/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, 
[email protected].

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

[[Page 48098]]

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation--                 19               1              19              40             760
 814.102........................
HDE Application--814.104........               3               1               3             320             960
HDE Amendments and resubmitted                 6               5              30              50           1,500
 HDEs--814.106..................
HDE Supplements--814.108........             110               1             110              80           8,800
Notification of withdrawal of an               1               1               1               1               1
 HDE--814.116(e)(3).............
Notification of withdrawal of                  1               1               1               2               2
 Institutional Review Board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              35               1              35             120           4,200
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          16,223
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers    recordkeeping       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2).........................................             247                1              247                2              494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)..........................              22                1               22                1               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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 
Sec.  814.126(b)(1) in table 1 reflects 35 respondents with approved 
HUD applications. Under Sec.  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

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

chemical residues (within the former food was so handled during the and food processing industries that
tolerance) after the tolerance for the acceptable timeframes. handle food products that may contain
pesticide chemical has been revoked, Examples of documentation that we residues of pesticide chemicals after the
suspended, or modified will be able to anticipate will serve this purpose tolerances for the pesticide chemicals
demonstrate that such food was consist of documentation associated have been revoked, suspended, or
handled, e.g., packed or processed, with packing codes, batch records, and modified.
during the acceptable timeframes cited inventory records. These are types of In the Federal Register of May 25,
in the guidance by providing documents that many food processors 2017 (82 FR 24133), we published a 60-
appropriate documentation to FDA as routinely generate as part of their basic day notice requesting public comment
discussed in the guidance document. food production operations. on the proposed extension of this
We are not suggesting that firms Accordingly, under the PRA, we are collection of information. One comment
maintain an inflexible set of documents requesting the extension of OMB was posted to the docket but did not
where anything less or different would approval for the information collection address any of the four information
likely be considered unacceptable. provisions in the guidance. collection topics solicited in our notice
Rather, we are leaving it to each firm’s Description of Respondents: The and so it is not discussed here.
discretion to maintain appropriate likely respondents to this collection of We therefore estimate the burden of
documentation to demonstrate that the information are firms in the produce this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses
Activity annual burden per Total hours
respondents per responses response
respondent

Submission of documentation .............................................. 1 1 1 3 3
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We expect the total number of the guidance document will also remain expect that the submitter will need to
pesticide tolerances that are revoked, at a low level. However, to avoid gather information from appropriate
suspended, or modified by EPA under counting this burden as zero, we have persons in the submitter’s company and
dietary risk considerations in the next 3 estimated the burden at one respondent to prepare this information for
years to remain at a low level, as there making one submission a year for a total submission to FDA. The submitter will
have been no changes to the safety of one annual submission. almost always merely need to copy
standard for pesticide residues in food We base our estimate of the hours per existing documentation. We believe that
since 1996. Thus, we expect the number response on the assumption that the this effort should take no longer than 3
of submissions we will receive under information requested in the guidance is hours per submission.
readily available to the submitter. We
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of records
Activity annual burden per Total hours
recordkeepers per records recordkeeping
recordkeeper

Develop documentation process ......................................... 1 1 1 16 16
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

In determining the estimated annual table 1 of this document, we estimate DEPARTMENT OF HEALTH AND
recordkeeping burden, we believe that that one respondent will make one HUMAN SERVICES
at least 90 percent of firms maintain submission per year. Although we
documentation, such as packing codes, estimate that only 1 out of 10 firms will Food and Drug Administration
batch records, and inventory records, as not be currently maintaining the
part of their basic food production or necessary documentation, to avoid [Docket No. FDA 2017–N–4951]
import operations. Therefore, the counting the recordkeeping burden for
recordkeeping burden was calculated as Agency Information Collection
the 1 submission per year as 1⁄10 of a
the time required for the 10 percent of Activities; Proposed Collection;
recordkeeper, we estimate that 1
firms that may not be currently Comment Request; Medical Devices;
recordkeeper will take 16 hours to
maintaining this documentation to Humanitarian Use Devices
develop and maintain documentation
develop and maintain documentation, recommended by the guidance. AGENCY: Food and Drug Administration,
ethrower on DSK3G9T082PROD with NOTICES

such as batch records and inventory HHS.
Dated: October 10, 2017.
records. In previous information ACTION: Notice.
collection requests, this recordkeeping Anna K. Abram,
burden was estimated to be 16 hours per Deputy Commissioner for Policy, Planning, SUMMARY: The Food and Drug
record. We retain our prior estimate of Legislation, and Analysis. Administration (FDA or Agency) is
16 hours per record for the [FR Doc. 2017–22285 Filed 10–13–17; 8:45 am] announcing an opportunity for public
recordkeeping burden. As shown in BILLING CODE 4164–01–P comment on the proposed collection 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 use of the device outweighs the risk of sections 514 and 515 of the FD&C Act,
(21 U.S.C. 360d and 360e) provided that injury or illness from its use, taking into provided that the device meets
the device: (1) Is designed to treat or account the probable risks and benefits requirements set forth under section
diagnose a disease or condition that of currently available devices or 520(m) of the FD&C Act; and (3)
affects no more than 8,000 individuals alternative forms of treatment. whether to grant marketing approval(s)
in the United States; (2) would not be Respondents may submit a for the HUD. Failure to collect this
available to a person with a disease or humanitarian device exemption (HDE) information would prevent FDA from
condition unless an exemption is application seeking exemption from the making a determination on the factors
effectiveness requirements of sections
granted and there is no comparable listed previously in this document.
514 and 515 of the FD&C Act as
device other than another HUD Further, the collected information
authorized by section 520(m)(2). The
approved under this exemption that is would also enable FDA to determine
information collected will assist FDA in
available to treat or diagnose such making determinations on the whether the holder of an HUD is in
disease or condition; and (3) will not following: (1) Whether to grant HUD compliance with the HUD provisions
expose patients to an unreasonable or designation of a medical device; (2) under section 520(m) of the FD&C Act.
significant risk of illness or injury and whether to exempt an HUD from the FDA estimates the burden of this
the probable benefit to health from the effectiveness requirements under collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response

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 ap-
proval—814.124(b) ........................................................... 1 1 1 2 2
Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200

Total .............................................................................. ........................ ........................ ........................ ........................ 16,223
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeping recordkeeping

HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent

Notification of emergency use—814.124(a) ........................ 22 1 22 1 22
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of respondents in tables There have been no program changes DEPARTMENT OF HEALTH AND
1, 2, and 3 of this document are an and the estimated Average Burden per HUMAN SERVICES
average based on data for the previous Response has not changed for any of the
3 years, i.e., fiscal years 2014 through information collections since the last Food and Drug Administration
2016. The number of annual reports OMB approval.
submitted under § 814.126(b)(1) in table [Docket No. FDA–2017–N–0001]
Dated: October 11, 2017.
1 reflects 35 respondents with approved
HUD applications. Under Anna K. Abram, Request for Nominations for
ethrower on DSK3G9T082PROD with NOTICES

§ 814.126(b)(2) in table 2, the estimated Deputy Commissioner for Policy, Planning, Individuals and Consumer
number of recordkeepers is 247. Legislation, and Analysis. Organizations for Advisory
The number of respondents has been [FR Doc. 2017–22320 Filed 10–13–17; 8:45 am]
Committees
adjusted to reflect updated respondent BILLING CODE 4164–01–P AGENCY: Food and Drug Administration,
data. This has resulted in an overall HHS.
decrease of 2,971 hours to the total
ACTION: Notice.
estimated annual reporting burden.

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Document Created: 2017-10-14 01:42:45
Document Modified: 2017-10-14 01:42:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by December 15, 2017.
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, [email protected]
FR Citation		82 FR 48096

82 FR 48096 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 198 (October 16, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration