81 FR 44627 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

Page Range		44627-44628
FR Document		2016-16158

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 the information collection associated with medical devices third-party review under the Food and Drug Administration Modernization Act.

Federal Register, Volume 81 Issue 131 (Friday, July 8, 2016)

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44627-44628]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16158]



[[Page 44627]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0795]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Third-Party Review Under the Food and 
Drug Administration Modernization Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 the information collection 
associated with medical devices third-party review under the Food and 
Drug Administration Modernization Act.

DATES: Submit either electronic or written comments on the collection 
of information by September 6, 2016.

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 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-2013-N-0795 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Devices; Third-Party 
Review Under the Food and Drug Administration Modernization Act.'' 
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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

[[Page 44628]]

Medical Devices; Third-Party Review Under the Food and Drug 
Administration Modernization Act--OMB Control Number 0910-0375--
Extension

    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m), directing FDA to accredit persons in the private 
sector to review certain premarket notifications (510(k)s). 
Participation in this third-party review program by accredited persons 
is entirely voluntary. A third party wishing to participate will submit 
a request for accreditation to FDA. Accredited third-party reviewers 
have the ability to review a manufacturer's 510(k) submission for 
selected devices. After reviewing a submission, the reviewer will 
forward a copy of the 510(k) submission, along with the reviewer's 
documented review and recommendation, to FDA. Third-party reviewers 
should maintain records of their 510(k) reviews and a copy of the 
510(k) for a reasonable period of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement 
the accredited person review program established by FDAMA and improve 
the efficiency of 510(k) review for low- to moderate-risk devices.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    FDA receives an average of one application for accreditation for 
third-party review per year. According to FDA's data, the number of 
510(k)s submitted for third-party review is approximately 260 annually, 
which is 26 annual reviews per each of the 10 accredited reviewers. 
Third-party reviewers are required to keep records of their review of 
each submission.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation......               1               1               1              24              24
510(k) reviews conducted by                   10              26             260              40          10,400
 accredited third parties.......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,424
----------------------------------------------------------------------------------------------------------------
\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
            Activity                 Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews..................              10              26             260              10           2,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16158 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-P

44628 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices

Medical Devices; Third-Party Review a request for accreditation to FDA. efficiency of 510(k) review for low- to
Under the Food and Drug Accredited third-party reviewers have moderate-risk devices.
Administration Modernization Act— the ability to review a manufacturer’s Respondents to this information
OMB Control Number 0910–0375— 510(k) submission for selected devices. collection are businesses or other for-
Extension After reviewing a submission, the profit organizations.
reviewer will forward a copy of the FDA receives an average of one
Section 210 of the Food and Drug 510(k) submission, along with the application for accreditation for third-
Administration Modernization Act reviewer’s documented review and party review per year. According to
(FDAMA) established section 523 of the recommendation, to FDA. Third-party FDA’s data, the number of 510(k)s
Federal Food, Drug, and Cosmetic Act reviewers should maintain records of submitted for third-party review is
(21 U.S.C. 360m), directing FDA to their 510(k) reviews and a copy of the approximately 260 annually, which is
accredit persons in the private sector to 510(k) for a reasonable period of time, 26 annual reviews per each of the 10
review certain premarket notifications usually a period of 3 years. accredited reviewers. Third-party
(510(k)s). Participation in this third- This information collection will allow reviewers are required to keep records
party review program by accredited FDA to continue to implement the of their review of each submission.
persons is entirely voluntary. A third accredited person review program FDA estimates the burden of this
party wishing to participate will submit established by FDAMA and improve the collection of information as follows:

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

Requests for accreditation ................................................... 1 1 1 24 24
510(k) reviews conducted by accredited third parties ......... 10 26 260 40 10,400

Total .............................................................................. ........................ ........................ ........................ ........................ 10,424
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 records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

510(k) reviews ...................................................................... 10 26 260 10 2,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 1, 2016. Elemental Impurities. The purpose of WhiteOakCampusInformation/
Leslie Kux, the public workshop is to elaborate key ucm241740.htm.
Associate Commissioner for Policy. aspects of the ICH Guideline Q3D: FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–16158 Filed 7–7–16; 8:45 am] Guideline on Elemental Impurities in Amanda Roache, Food and Drug
BILLING CODE 4164–01–P
order facilitate a harmonized Administration, 10903 New Hampshire
interpretation and implementation by Ave., Bldg. 51, Rm. 1176, Silver Spring,
industry and regulators. It is not MD 20993, 301–796–4548, email:
DEPARTMENT OF HEALTH AND intended to provide additional guidance Amanda.Roache@fda.hhs.gov.
HUMAN SERVICES beyond the scope of Q3D. The meeting
SUPPLEMENTARY INFORMATION: The ICH
will take place on the FDA campus and
Food and Drug Administration also be broadcast on the Web allowing brings together regulatory authorities
participants to join in person or via the and pharmaceutical industry to discuss
[Docket No. FDA–2016–N–0001] scientific and technical aspects of drug
Web.
registration. The ICH’s mission is to
Regional Public Workshop on the DATES: The public workshop will be achieve greater harmonization
International Council for held on August 22 and 23, from 9 a.m. worldwide to ensure that safe, effective,
Harmonization of Technical to 5 p.m., EST. See the SUPPLEMENTARY and high quality medicines are
Requirements for Pharmaceuticals for INFORMATION section for information on developed and registered in the most
Human Use Q3D Implementation of how to register. resource-efficient manner. The ICH Q3D
Guideline for Elemental Impurities; ADDRESSES: The public workshop will Guideline was developed by the ICH to
Public Workshop be held at 10903 New Hampshire Ave., provide a global policy for limiting
Bldg. 31, Rm. 1503B/C, Silver Spring, elemental impurities qualitatively and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

AGENCY: Food and Drug Administration,
HHS. MD 20993. The entrance for the public quantitatively in drug products and
ACTION: Notice of public workshop. workshop participants (non-FDA ingredients. Following finalization of
employees) is through Building 1 where this Guideline, an Implementation
SUMMARY: The Food and Drug routine security check procedures will Working Group was established to
Administration (FDA) is announcing a be performed. For parking and security develop a comprehensive training
public workshop entitled: Regional information, please refer to http:// program and supporting documents
Public Workshop on ICH Q3D www.fda.gov/AboutFDA/ sponsored by ICH to ensure the proper
Implementation of Guideline for WorkingatFDA/BuildingsandFacilities/ interpretation and effective utilization

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Document Created: 2016-07-08 00:18:03
Document Modified: 2016-07-08 00:18:03

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 September 6, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 44627

81 FR 44627 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration