[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65779-65781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27199]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3815]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission of Medical Device Registration
and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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
associated with electronic submission of medical device registration
and listing.
DATES: Submit either electronic or written comments on the collection
of information by December 28, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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
[[Page 65780]]
information, or other information that identifies you in the body of
your comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-3815 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Submission of Medical
Device Registration and Listing.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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.
Electronic Submission of Medical Device Registration and Listing--21
CFR Part 807, Subparts A Through E; OMB Control Number 0910-0625--
Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR
part 807, subparts A through D), medical device establishment owners
and operators are required to electronically submit establishment
registration and device listing information.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: (1) Identification of establishments producing
marketed medical devices, (2) identification of establishments
producing a specific device when that device is in short supply or is
needed for national emergency, (3) facilitation of recalls for devices
marketed by owners and operators of device establishments, (4)
identification and cataloguing of marketed devices, (5) administering
postmarketing surveillance programs for devices, (6) identification of
devices marketed in violation of the law, (7) identification and
control of devices imported into the country from foreign
establishments, (8) and scheduling and planning inspections of
registered establishments under section 704 of the FD&C Act (21 U.S.C.
374)
Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and submit listing information for
each of their devices in commercial distribution. Notwithstanding
certain exceptions, foreign device establishments that manufacture,
prepare, propagate, compound, or process a device that is imported or
offered for import into the United States must also comply with the
registration and listing requirements. The number of respondents is
based on data from the FDA Unified Registration and Listing System.
Burden estimates are based on recent experience with the existing
medical device registration and listing program, electronic system
operating experience, and the economic analysis for the final
[[Page 65781]]
rule entitled ``Implementation of Device Registration and Listing
Requirements Enacted in the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the Medical Device User Fee and
Modernization Act of 2002, and Title II of the Food and Drug
Administration Amendments Act of 2007.''
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)(5) \2\--Submittal of manufacturer information 3673 8,594 1 8,594 1.75 15,040
by initial importers...................................
807.20(a)(5) \3\--Submittal of manufacturer information 3673 8,594 3 25,782 0.1 2,578
by initial importers...................................
807.21(a) \3\--Creation of electronic system account.... 3673 3,559 1 3,559 0.5 1,780
807.21(b) \2\--Annual request for waiver from electronic .............. 14 1 14 1 14
registration & listing.................................
807.21(b) \3\--Initial request for waiver from .............. 4 1 4 1 4
electronic registration & listing......................
807.22(a) \3\--Initial registration & listing........... 3673 3,539 1 3,539 0.5 1,770
807.22(b)(1) \3\--Annual registration................... 3673 20,355 1 20,355 0.75 15,266
807.22(b)(2) \3\--Other updates of registration......... 3673 4,176 1 4,176 0.5 2,088
807.22(b)(3) \3\--Annual update of listing information.. 3673 19,875 1 19,875 1 19,875
807.26(e) \3\--Labeling & advertisement submitted at FDA .............. 71 1 71 1 71
request................................................
807.34(a) \2\--Initial registration & listing when .............. 14 1 14 1 14
electronic filing waiver granted.......................
807.34(a) \3\--Annual registration & listing when .............. 4 1 4 1 4
electronic filing waiver granted.......................
807.40(b)(2) \3\--Annual update of US agent information. 3673 1,615 1 1,615 0.5 808
807.40(b)(3) \3\--US agent responses to FDA requests for 3673 1,535 1 1,535 0.25 384
information............................................
807.41(a) \3\--Identification of initial importers by 3673 10,329 1 10,329 0.5 5,165
foreign establishments.................................
807.41(b) \3\--Identification of other parties that 3673 10,329 1 10,329 0.5 5,165
facilitate import by foreign establishments............
-----------------------------------------------------------------------------------------------
Total on-time burden................................ .............. .............. .............. .............. .............. 15,068
Total recurring burden.............................. .............. .............. .............. .............. .............. 54,958
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One-time burden.
\3\ Recurring burden.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
807.25(d) \2\--List of Officers, 23,806 1 23,806 0.25 5,952
Directors & Partners...........
807.26 \2\--Labeling & 11,746 4 46,984 0.5 23,492
Advertisements Available for
Review.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 29,444
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden.
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27199 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P