81_FR_2230 81 FR 2220 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

81 FR 2220 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 10 (January 15, 2016)

Page Range2220-2222
FR Document2016-00691

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 to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN).

Federal Register, Volume 81 Issue 10 (Friday, January 15, 2016)
[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2220-2222]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00691]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1203]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Information To Accompany Humanitarian Device Exemption 
Applications and Annual Distribution Number Reporting Requirements

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 information to accompany 
humanitarian device exemption (HDE) applications and the collection of 
information regarding the annual distribution number (ADN).

DATES: Submit either electronic or written comments on the collection 
of information by March 15, 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

[[Page 2221]]

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-2012-N-1203 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Information to Accompany 
Humanitarian Device Exemption Applications and Annual Distribution 
Number Reporting Requirements''. 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.

Information To Accompany Humanitarian Device Exemption Applications and 
Annual Distribution Number Reporting Requirements--OMB Control Number 
0910-0661--Extension

    Under section 520(m) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360j(m)), FDA is authorized to exempt a 
humanitarian use device (HUD) from the effectiveness requirements in 
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided 
that the device: (1) Is used to treat or diagnose a disease or 
condition that affects fewer than 4,000 individuals in the United 
States; (2) would not be available to a person with such a disease or 
condition unless the exemption is granted, and there is no comparable 
device, other than another HUD approved under this exemption, available 
to treat or diagnose the disease or condition; (3) the device will not 
expose patients to an unreasonable or significant risk of illness or 
injury; and (4) the probable benefit to health from using 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.
    HUDs approved under an HDE cannot be sold for an amount that 
exceeds the costs of research and development, fabrication, and 
distribution of the device (i.e., for profit), except in narrow 
circumstances. Section 613 of the Food and Drug Administration Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 
9, 2012, amended section 520(m) of the FD&C Act. Under section 
520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD approved 
under an HDE is eligible to be sold for profit if the device meets the 
following criteria: The device is intended for the treatment or 
diagnosis of a disease or condition that occurs in pediatric patients 
or in a pediatric subpopulation, and such device is labeled for use in 
pediatric patients or in a pediatric subpopulation in which the disease 
or condition occurs; or the device is intended for the treatment or 
diagnosis of a disease or condition that does not occur in pediatric 
patients, or that occurs in pediatric patients in such numbers that the 
development of the device for such patients is impossible, highly 
impracticable, or unsafe.
    Section 520(m)(6)(A)(ii) of the FD&C Act, as amended by FDASIA, 
provides that the Secretary of Health and Human Services will assign an 
ADN for devices that meet the eligibility criteria to be permitted to 
be sold for profit. The ADN is defined as the number of devices

[[Page 2222]]

``reasonably needed to treat, diagnose, or cure a population of 4,000 
individuals in the United States'', and therefore shall be based on the 
following information in a HDE application: The number of devices 
reasonably necessary to treat such individuals.
    Section 520(m)(6)(A)(iii) of the FD&C Act (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm) provides that an HDE holder 
immediately notify the Agency if the number of devices distributed 
during any calendar year exceeds the ADN. Section 520(m)(6)(C) of the 
FD&C Act provides that an HDE holder may petition to modify the ADN if 
additional information arises.
    On August 5, 2008, FDA issued a guidance entitled ``Guidance for 
HDE Holders, Institutional Review Boards (IRBs), Clinical 
Investigators, and Food and Drug Administration Staff--Humanitarian 
Device Exemption (HDE) Regulation: Questions and Answers'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf). The guidance was developed and issued 
prior to the enactment of FDASIA, and certain sections of this guidance 
may no longer be current as a result of FDASIA. In the Federal Register 
of March 18, 2014 (79 FR 15130), FDA announced the availability of the 
draft guidance entitled ``Humanitarian Device Exemption: Questions and 
Answers; Draft Guidance for Humanitarian Device Exemption Holders, 
Institutional Review Boards, Clinical Investigators, and Food and Drug 
Administration Staff'', that when finalized, will represent FDA's 
current thinking on this topic.
    FDA is requesting the extension of OMB approval for the collection 
of information required under the statutory mandate of sections 515A 
(21 U.S.C. 360e-1) and 520(m) of the FD&C Act as amended.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Activity/section of FD&C Act (as     Number of     responses per   Total annual   Average burden    Total hours
       amended) or FDASIA           respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Pediatric Subpopulation and                    6               1               6             100             600
 Patient Information--515A(a)(2)
 of the FD&C Act................
Exemption from Profit                          3               1               3              50             150
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   2               1               2              10              20
 Eligibility Criteria--613(b) of
 FDASIA.........................
ADN Notification--                             1               1               1             100             100
 520(m)(6)(A)(iii) of the FD&C
 Act............................
ADN Modification--520(m)(6)(C)                 5               1               5             100             500
 of the FD&C Act................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,370
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's Center for Devices and Radiological Health receives an 
estimated average of six HDE applications per year. FDA estimates that 
three of these applications will be indicated for pediatric use. We 
estimate that we will receive approximately two requests for 
determination of eligibility criteria per year. FDA estimates that very 
few or no HDE holders will notify the Agency that the number of devices 
distributed in the year has exceeded the ADN. FDA estimates that five 
HDE holders will petition to have the ADN modified due to additional 
information on the number of individuals affected by the disease or 
condition.

    Dated: January 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00691 Filed 1-14-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                  2220                           Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices

                                                  Vaccines and Related Biological                           The Commissioner or designee shall                   DEPARTMENT OF HEALTH AND
                                                  Products Advisory Committee. The                        have the authority to select members of                HUMAN SERVICES
                                                  committee is a discretionary Federal                    other scientific and technical FDA
                                                  advisory committee established to                       advisory committees (normally not to                   Food and Drug Administration
                                                  provide advice to the Commissioner.                     exceed 10 members) to serve                            [Docket No. FDA–2012–N–1203]
                                                  The Vaccines and Related Biological                     temporarily as voting members and to
                                                  Products Advisory Committee advises                     designate consultants to serve                         Agency Information Collection
                                                  the Commissioner or designee in                         temporarily as voting members when:                    Activities; Proposed Collection;
                                                  discharging responsibilities as they                    (1) Expertise is required that is not                  Comment Request; Information To
                                                  relate to helping to ensure safe and                                                                           Accompany Humanitarian Device
                                                                                                          available among current voting standing
                                                  effective vaccines and related biological                                                                      Exemption Applications and Annual
                                                                                                          members of the Committee (when
                                                  products for human use and, as                                                                                 Distribution Number Reporting
                                                  required, any other product for which                   additional voting members are added to
                                                                                                          the Committee to provide needed                        Requirements
                                                  the Food and Drug Administration has
                                                  regulatory responsibility.                              expertise, a quorum will be based on the               AGENCY:   Food and Drug Administration,
                                                     The Committee reviews and evaluates                  combined total of regular and added                    HHS.
                                                  data concerning the safety,                             members), or (2) to comprise a quorum                  ACTION:   Notice.
                                                  effectiveness, and appropriate use of                   when, because of unforeseen
                                                  vaccines and related biological products                circumstances, a quorum is or will be                  SUMMARY:  The Food and Drug
                                                  which are intended for use in the                       lacking. Because of the size of the                    Administration (FDA) is announcing an
                                                  prevention, treatment, or diagnosis of                  Committee and the variety in the types                 opportunity for public comment on the
                                                  human diseases, and, as required, any                                                                          proposed collection of certain
                                                                                                          of issues that it will consider, FDA may,
                                                  other products for which the Food and                                                                          information by the Agency. Under the
                                                                                                          in connection with a particular
                                                  Drug Administration has regulatory                                                                             Paperwork Reduction Act of 1995 (the
                                                                                                          committee meeting, specify a quorum                    PRA), Federal Agencies are required to
                                                  responsibility. The Committee also                      that is less than a majority of the current
                                                  considers the quality and relevance of                                                                         publish notice in the Federal Register
                                                                                                          voting members. The Agency’s                           concerning each proposed collection of
                                                  FDA’s research program which provides                   regulations (21 CFR 14.22(d)) authorize
                                                  scientific support for the regulation of                                                                       information, including each proposed
                                                                                                          a committee charter to specify quorum                  extension of an existing collection of
                                                  these products and makes appropriate                    requirements. If functioning as a
                                                  recommendations to the Commissioner                                                                            information, and to allow 60 days for
                                                                                                          medical device panel, a non-voting                     public comment in response to the
                                                  of Food and Drugs.
                                                     The Committee shall consist of a core                representative of consumer interests and               notice. This notice solicits comments on
                                                  of 15 voting members including the                      a non-voting representative of industry                information to accompany humanitarian
                                                  Chair. Members and the Chair are                        interests will be included in addition to              device exemption (HDE) applications
                                                  selected by the Commissioner or                         the voting members.                                    and the collection of information
                                                  designee from among authorities                           Further information regarding the                    regarding the annual distribution
                                                  knowledgeable in the fields of                          most recent charter and other                          number (ADN).
                                                  immunology, molecular biology, rDNA,                    information can be found at http://                    DATES: Submit either electronic or
                                                  virology; bacteriology, epidemiology or                 www.fda.gov/AdvisoryCommittees/                        written comments on the collection of
                                                  biostatistics, vaccine policy, vaccine                  CommitteesMeetingMaterials/                            information by March 15, 2016.
                                                  safety science, federal immunization                    BloodVaccinesandOtherBiologics/                        ADDRESSES: You may submit comments
                                                  activities, vaccine development                         VaccinesandRelated                                     as follows:
                                                  including translational and clinical
                                                                                                          BiologicalProductsAdvisoryCommittee/                   Electronic Submissions
                                                  evaluation programs, allergy, preventive
                                                                                                          ucm129571.htm or by contacting the                       Submit electronic comments in the
                                                  medicine, infectious diseases,
                                                  pediatrics, microbiology, and                           Designated Federal Officer (see FOR                    following way:
                                                                                                          FURTHER INFORMATION CONTACT). In light                   • Federal eRulemaking Portal: http://
                                                  biochemistry. Members will be invited
                                                  to serve for overlapping terms of up to                 of the fact that no change has been made               www.regulations.gov. Follow the
                                                  four years. Almost all non-Federal                      to the committee name or description of                instructions for submitting comments.
                                                  members of this committee serve as                      duties, no amendment will be made to                   Comments submitted electronically,
                                                  Special Government Employees. Ex                        21 CFR 14.100.                                         including attachments, to http://
                                                  Officio voting members one each from                      This document is issued under the                    www.regulations.gov will be posted to
                                                  the Department of Health and Human                      Federal Advisory Committee Act (5                      the docket unchanged. Because your
                                                  Services, the Centers for Disease Control               U.S.C. app.). For general information                  comment will be made public, you are
                                                  and Prevention, and the National                        related to FDA advisory committees,                    solely responsible for ensuring that your
                                                  Institutes of Health may be included.                   please visit us at http://www.fda.gov/                 comment does not include any
                                                  The core of voting members may                          AdvisoryCommittees/default.htm.                        confidential information that you or a
                                                  include one technically qualified                                                                              third party may not wish to be posted,
                                                  member, selected by the Commissioner                       Dated: January 11, 2016.                            such as medical information, your or
                                                  or designee, who is identified with                     Jill Hartzler Warner,                                  anyone else’s Social Security number, or
                                                  consumer interests and is recommended                   Associate Commissioner for Special Medical             confidential business information, such
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  by either a consortium of consumer-                     Programs.                                              as a manufacturing process. Please note
                                                  oriented organizations or other                         [FR Doc. 2016–00675 Filed 1–14–16; 8:45 am]            that if you include your name, contact
                                                  interested persons. In addition to the                  BILLING CODE 4164–01–P
                                                                                                                                                                 information, or other information that
                                                  voting members, the Committee may                                                                              identifies you in the body of your
                                                  include one non-voting member who is                                                                           comments, that information will be
                                                  identified with industry interests. There                                                                      posted on http://www.regulations.gov.
                                                  may also be an alternate industry                                                                                • If you want to submit a comment
                                                  representative.                                                                                                with confidential information that you


                                             VerDate Sep<11>2014   20:01 Jan 14, 2016   Jkt 238001   PO 00000   Frm 00061   Fmt 4703   Sfmt 4703   E:\FR\FM\15JAN1.SGM   15JAN1


                                                                                 Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices                                             2221

                                                  do not wish to be made available to the                 applicable disclosure law. For more                    Information To Accompany
                                                  public, submit the comment as a                         information about FDA’s posting of                     Humanitarian Device Exemption
                                                  written/paper submission and in the                     comments to public dockets, see 80 FR                  Applications and Annual Distribution
                                                  manner detailed (see ‘‘Written/Paper                    56469, September 18, 2015, or access                   Number Reporting Requirements—
                                                  Submissions’’ and ‘‘Instructions’’).                    the information at: http://www.fda.gov/                OMB Control Number 0910–0661—
                                                                                                          regulatoryinformation/dockets/                         Extension
                                                  Written/Paper Submissions
                                                                                                          default.htm.                                              Under section 520(m) of the Federal
                                                     Submit written/paper submissions as                     Docket: For access to the docket to
                                                  follows:                                                                                                       Food, Drug, and Cosmetic Act (the
                                                                                                          read background documents or the
                                                     • Mail/Hand delivery/Courier (for                                                                           FD&C Act) (21 U.S.C. 360j(m)), FDA is
                                                                                                          electronic and written/paper comments
                                                  written/paper submissions): Division of                                                                        authorized to exempt a humanitarian
                                                                                                          received, go to http://
                                                  Dockets Management (HFA–305), Food                                                                             use device (HUD) from the effectiveness
                                                                                                          www.regulations.gov and insert the
                                                  and Drug Administration, 5630 Fishers                                                                          requirements in sections 514 and 515 of
                                                                                                          docket number, found in brackets in the
                                                  Lane, Rm. 1061, Rockville, MD 20852.                                                                           the FD&C Act (21 U.S.C. 360d and 360e)
                                                                                                          heading of this document, into the
                                                     • For written/paper comments                         ‘‘Search’’ box and follow the prompts
                                                                                                                                                                 provided that the device: (1) Is used to
                                                  submitted to the Division of Dockets                                                                           treat or diagnose a disease or condition
                                                                                                          and/or go to the Division of Dockets
                                                  Management, FDA will post your                                                                                 that affects fewer than 4,000 individuals
                                                                                                          Management, 5630 Fishers Lane, Rm.
                                                  comment, as well as any attachments,                                                                           in the United States; (2) would not be
                                                                                                          1061, Rockville, MD 20852.
                                                  except for information submitted,                                                                              available to a person with such a disease
                                                                                                          FOR FURTHER INFORMATION CONTACT: FDA                   or condition unless the exemption is
                                                  marked and identified, as confidential,
                                                                                                          PRA Staff, Office of Operations, Food                  granted, and there is no comparable
                                                  if submitted as detailed in
                                                                                                          and Drug Administration, 8455                          device, other than another HUD
                                                  ‘‘Instructions.’’
                                                     Instructions: All submissions received               Colesville Rd., COLE–14526, Silver                     approved under this exemption,
                                                  must include the Docket No. FDA–                        Spring, MD 20993–0002, PRAStaff@                       available to treat or diagnose the disease
                                                  2012–N–1203 for ‘‘Agency Information                    fda.hhs.gov.                                           or condition; (3) the device will not
                                                  Collection Activities; Proposed                         SUPPLEMENTARY INFORMATION: Under the                   expose patients to an unreasonable or
                                                  Collection; Comment Request;                            PRA (44 U.S.C. 3501–3520), Federal                     significant risk of illness or injury; and
                                                  Information to Accompany                                Agencies must obtain approval from the                 (4) the probable benefit to health from
                                                  Humanitarian Device Exemption                           Office of Management and Budget                        using the device outweighs the risk of
                                                  Applications and Annual Distribution                    (OMB) for each collection of                           injury or illness from its use, taking into
                                                  Number Reporting Requirements’’.                        information they conduct or sponsor.                   account the probable risks and benefits
                                                  Received comments will be placed in                     ‘‘Collection of information’’ is defined               of currently available devices or
                                                  the docket and, except for those                        in 44 U.S.C. 3502(3) and 5 CFR                         alternative forms of treatment.
                                                  submitted as ‘‘Confidential                             1320.3(c) and includes Agency requests                    HUDs approved under an HDE cannot
                                                  Submissions,’’ publicly viewable at                     or requirements that members of the                    be sold for an amount that exceeds the
                                                  http://www.regulations.gov or at the                    public submit reports, keep records, or                costs of research and development,
                                                  Division of Dockets Management                          provide information to a third party.                  fabrication, and distribution of the
                                                  between 9 a.m. and 4 p.m., Monday                       Section 3506(c)(2)(A) of the PRA (44                   device (i.e., for profit), except in narrow
                                                  through Friday.                                         U.S.C. 3506(c)(2)(A)) requires Federal                 circumstances. Section 613 of the Food
                                                     • Confidential Submissions—To                        Agencies to provide a 60-day notice in                 and Drug Administration Safety and
                                                  submit a comment with confidential                      the Federal Register concerning each                   Innovation Act (FDASIA) (Pub. L. 112–
                                                  information that you do not wish to be                  proposed collection of information,                    144), signed into law on July 9, 2012,
                                                  made publicly available, submit your                    including each proposed extension of an                amended section 520(m) of the FD&C
                                                  comments only as a written/paper                        existing collection of information,                    Act. Under section 520(m)(6)(A)(i) of the
                                                  submission. You should submit two                       before submitting the collection to OMB                FD&C Act, as amended by FDASIA, a
                                                  copies total. One copy will include the                 for approval. To comply with this                      HUD approved under an HDE is eligible
                                                  information you claim to be confidential                requirement, FDA is publishing notice                  to be sold for profit if the device meets
                                                  with a heading or cover note that states                of the proposed collection of                          the following criteria: The device is
                                                  ‘‘THIS DOCUMENT CONTAINS                                information set forth in this document.                intended for the treatment or diagnosis
                                                  CONFIDENTIAL INFORMATION’’. The                            With respect to the following                       of a disease or condition that occurs in
                                                  Agency will review this copy, including                 collection of information, FDA invites                 pediatric patients or in a pediatric
                                                  the claimed confidential information, in                comments on these topics: (1) Whether                  subpopulation, and such device is
                                                  its consideration of comments. The                      the proposed collection of information                 labeled for use in pediatric patients or
                                                  second copy, which will have the                        is necessary for the proper performance                in a pediatric subpopulation in which
                                                  claimed confidential information                        of FDA’s functions, including whether                  the disease or condition occurs; or the
                                                  redacted/blacked out, will be available                 the information will have practical                    device is intended for the treatment or
                                                  for public viewing and posted on                        utility; (2) the accuracy of FDA’s                     diagnosis of a disease or condition that
                                                  http://www.regulations.gov. Submit                      estimate of the burden of the proposed                 does not occur in pediatric patients, or
                                                  both copies to the Division of Dockets                  collection of information, including the               that occurs in pediatric patients in such
                                                  Management. If you do not wish your                     validity of the methodology and                        numbers that the development of the
                                                  name and contact information to be                      assumptions used; (3) ways to enhance                  device for such patients is impossible,
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  made publicly available, you can                        the quality, utility, and clarity of the               highly impracticable, or unsafe.
                                                  provide this information on the cover                   information to be collected; and (4)                      Section 520(m)(6)(A)(ii) of the FD&C
                                                  sheet and not in the body of your                       ways to minimize the burden of the                     Act, as amended by FDASIA, provides
                                                  comments and you must identify this                     collection of information on                           that the Secretary of Health and Human
                                                  information as ‘‘confidential.’’ Any                    respondents, including through the use                 Services will assign an ADN for devices
                                                  information marked as ‘‘confidential’’                  of automated collection techniques,                    that meet the eligibility criteria to be
                                                  will not be disclosed except in                         when appropriate, and other forms of                   permitted to be sold for profit. The ADN
                                                  accordance with 21 CFR 10.20 and other                  information technology.                                is defined as the number of devices


                                             VerDate Sep<11>2014   20:01 Jan 14, 2016   Jkt 238001   PO 00000   Frm 00062   Fmt 4703   Sfmt 4703   E:\FR\FM\15JAN1.SGM   15JAN1


                                                  2222                                      Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices

                                                  ‘‘reasonably needed to treat, diagnose,                                    petition to modify the ADN if additional                                     availability of the draft guidance
                                                  or cure a population of 4,000                                              information arises.                                                          entitled ‘‘Humanitarian Device
                                                  individuals in the United States’’, and                                       On August 5, 2008, FDA issued a                                           Exemption: Questions and Answers;
                                                  therefore shall be based on the following                                  guidance entitled ‘‘Guidance for HDE                                         Draft Guidance for Humanitarian Device
                                                  information in a HDE application: The                                      Holders, Institutional Review Boards                                         Exemption Holders, Institutional
                                                  number of devices reasonably necessary                                     (IRBs), Clinical Investigators, and Food                                     Review Boards, Clinical Investigators,
                                                  to treat such individuals.                                                 and Drug Administration Staff—                                               and Food and Drug Administration
                                                                                                                             Humanitarian Device Exemption (HDE)                                          Staff’’, that when finalized, will
                                                     Section 520(m)(6)(A)(iii) of the FD&C                                   Regulation: Questions and Answers’’
                                                  Act (http://www.fda.gov/Regulatory                                                                                                                      represent FDA’s current thinking on this
                                                                                                                             (http://www.fda.gov/downloads/                                               topic.
                                                  Information/Legislation/Federal                                            MedicalDevices/DeviceRegulationand
                                                  FoodDrugandCosmeticActFDCAct/                                              Guidance/GuidanceDocuments/                                                    FDA is requesting the extension of
                                                  FDCActChapterVDrugsandDevices/                                             ucm110203.pdf). The guidance was                                             OMB approval for the collection of
                                                  default.htm) provides that an HDE                                          developed and issued prior to the                                            information required under the statutory
                                                  holder immediately notify the Agency if                                    enactment of FDASIA, and certain                                             mandate of sections 515A (21 U.S.C.
                                                  the number of devices distributed                                          sections of this guidance may no longer                                      360e–1) and 520(m) of the FD&C Act as
                                                  during any calendar year exceeds the                                       be current as a result of FDASIA. In the                                     amended.
                                                  ADN. Section 520(m)(6)(C) of the FD&C                                      Federal Register of March 18, 2014 (79                                         FDA estimates the burden of this
                                                  Act provides that an HDE holder may                                        FR 15130), FDA announced the                                                 collection of information as follows:

                                                                                                                 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
                                                                                                                                                                             Number of                                                Average
                                                                                                                                                  Number of                                            Total annual
                                                     Activity/section of FD&C Act (as amended) or FDASIA                                                                   responses per                                            burden per              Total hours
                                                                                                                                                 respondents                                            responses
                                                                                                                                                                             respondent                                              response

                                                  Pediatric Subpopulation and Patient Information—
                                                    515A(a)(2) of the FD&C Act .............................................                                          6                          1                         6                       100               600
                                                  Exemption     from         Profit         Prohibition           Information—
                                                    520(m)(6)(A)(i) and (ii) of the FD&C Act ..........................                                               3                         1                           3                        50              150
                                                  Request for Determination of Eligibility Criteria—613(b) of
                                                    FDASIA .............................................................................                             2                           1                         2                       10                 20
                                                  ADN Notification—520(m)(6)(A)(iii) of the FD&C Act ..........                                                      1                           1                         1                      100                100
                                                  ADN Modification—520(m)(6)(C) of the FD&C Act .............                                                        5                           1                         5                      100                500

                                                        Total ..............................................................................    ........................   ........................   ........................   ........................          1,370
                                                     1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    FDA’s Center for Devices and                                             DEPARTMENT OF HEALTH AND                                                     dysfunction caused by drugs used
                                                  Radiological Health receives an                                            HUMAN SERVICES                                                               during clinical trials.
                                                  estimated average of six HDE                                                                                                                            DATES: This public conference will be
                                                  applications per year. FDA estimates                                       Food and Drug Administration                                                 held on March 23, 2016, from 8 a.m. to
                                                  that three of these applications will be                                                                                                                6 p.m., and on March 24, 2016, from 8
                                                  indicated for pediatric use. We estimate                                   [Docket No. FDA–2008–D–0128 (formerly                                        a.m. to 4 p.m.
                                                                                                                             Docket No. 2007D–0396)]
                                                  that we will receive approximately two                                                                                                                  ADDRESSES: This public conference will
                                                  requests for determination of eligibility                                  How Should Liver Injury and                                                  be held at the College Park Marriott
                                                  criteria per year. FDA estimates that                                      Dysfunction Caused by Drugs Be                                               Hotel & Conference Center, 3501
                                                  very few or no HDE holders will notify                                     Measured, Evaluated, and Acted Upon                                          University Blvd., East Hyattsville, MD
                                                  the Agency that the number of devices                                      in Clinical Trials?                                                          20783. The hotel’s phone number is
                                                  distributed in the year has exceeded the                                                                                                                301–985–7300.
                                                  ADN. FDA estimates that five HDE                                           AGENCY:           Food and Drug Administration,                              FOR FURTHER INFORMATION CONTACT:
                                                  holders will petition to have the ADN                                      HHS.                                                                         Lana L. Pauls, Center for Drug
                                                  modified due to additional information                                     ACTION:       Notice of public conference.                                   Evaluation and Research, Food and
                                                  on the number of individuals affected                                                                                                                   Drug Administration, 10903 New
                                                                                                                             SUMMARY:   The Food and Drug                                                 Hampshire Ave., Bldg. 22, Rm. 4478,
                                                  by the disease or condition.
                                                                                                                             Administration (FDA) is announcing a                                         Silver Spring, MD 20993–0002, 301–
                                                    Dated: January 11, 2016.                                                 public conference entitled ‘‘How Should                                      796–0518, lana.pauls@fda.hhs.gov.
                                                  Leslie Kux,                                                                Liver Injury and Dysfunction Caused by                                       SUPPLEMENTARY INFORMATION:
                                                  Associate Commissioner for Policy.                                         Drugs Be Measured, Evaluated, and
                                                                                                                             Acted Upon in Clinical Trials?’’ This                                        I. Background
                                                  [FR Doc. 2016–00691 Filed 1–14–16; 8:45 am]
                                                                                                                             conference will be cosponsored with the                                         In July 2009, FDA announced the
                                                  BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                                             Critical Path Institute (C-Path). The                                        availability of a guidance for industry
                                                                                                                             purpose of the conference is to discuss,                                     entitled ‘‘Drug-Induced Liver Injury:
                                                                                                                             debate, and share views among                                                Premarketing Clinical Evaluation’’ (74
                                                                                                                             stakeholders in academia, patient                                            FR 38035, July 30, 2009, https://
                                                                                                                             groups, regulatory bodies, and the                                           www.gpo.gov/fdsys/pkg/FR-2009-07-30/
                                                                                                                             health care and pharmaceutical                                               pdf/E9-18135.pdf). First, this guidance
                                                                                                                             industries on how best to measure,                                           explains that drug-induced liver injury
                                                                                                                             evaluate, and act upon liver injury and                                      (DILI) has been the most frequent cause


                                             VerDate Sep<11>2014        20:01 Jan 14, 2016         Jkt 238001       PO 00000        Frm 00063        Fmt 4703       Sfmt 4703       E:\FR\FM\15JAN1.SGM              15JAN1



Document Created: 2018-02-02 12:32:03
Document Modified: 2018-02-02 12:32:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by March 15, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 2220 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR