81_FR_30633 81 FR 30538 - Information Collection Being Reviewed by the Federal Communications Commission

81 FR 30538 - Information Collection Being Reviewed by the Federal Communications Commission

FEDERAL COMMUNICATIONS COMMISSION

Federal Register Volume 81, Issue 95 (May 17, 2016)

Page Range30538-30540
FR Document2016-11583

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

Federal Register, Volume 81 Issue 95 (Tuesday, May 17, 2016)
[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30538-30540]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11583]


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FEDERAL COMMUNICATIONS COMMISSION

[OMB 3060-0207]


Information Collection Being Reviewed by the Federal 
Communications Commission

AGENCY: Federal Communications Commission.

ACTION: Notice and request for comments.

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

SUMMARY: As part of its continuing effort to reduce paperwork burdens, 
and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 
3501-3520), the Federal Communications Commission (FCC or the 
Commission) invites the general public and other Federal agencies to 
take this opportunity to comment on the following information 
collection. Comments are requested concerning: Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the Commission, including whether the information 
shall have practical utility; the accuracy of the Commission's burden 
estimate; ways to enhance the quality, utility, and clarity of the 
information collected; ways to minimize the burden of the collection of 
information on the respondents, including the use of automated 
collection techniques or other forms of information technology; and 
ways to further reduce the information collection burden on small 
business concerns with fewer than 25 employees.
    The FCC may not conduct or sponsor a collection of information 
unless it displays a currently valid control number. No person shall be 
subject to any penalty for failing to comply with a collection of 
information subject to the PRA that does not display a valid Office of 
Management and Budget (OMB) control number.

DATES: Written PRA comments should be submitted on or before July 18, 
2016. If you anticipate that you will be submitting comments, but find 
it difficult to do so within the period of time allowed by this notice, 
you should advise the contact listed below as soon as possible.

ADDRESSES: Direct all PRA comments to Nicole Ongele, FCC, via email 
[email protected] and to [email protected].

FOR FURTHER INFORMATION CONTACT: For additional information about the 
information collection, contact Nicole Ongele at (202) 418-2991.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 3060-0207.
    Title: Part 11--Emergency Alert System (EAS), Order, FCC 16-32.
    Form Number: N/A.
    Type of Review: Revision of a currently approved collection.
    Respondents: Business or other for-profit entities, not-for-profit 
institutions, and state, local or tribal government.
    Number of Respondents and Responses: 63,080 respondents; 3,596,546 
responses.
    Estimated Time per Response: 1 hour (EAS Participants); 20 hours 
(SECCs).
    Frequency of Response: One-time reporting requirement and 
recordkeeping requirement.
    Obligation to Respond: Obligatory for all entities required to 
participate in

[[Page 30539]]

EAS. Statutory authority for this collection of information is 
contained in 47 U.S.C. 154(i) and 606 of the Communications Act of 
1934, as amended.
    Total Annual Burden: 110,476 hours.
    Total Annual Cost: No cost.
    Privacy Impact Assessment: No Impact(s).
    Nature and Extent of Confidentiality: There is no need for 
confidentiality.
    Needs and Uses: Part 11 contains rules and regulations addressing 
the nation's Emergency Alert System (EAS). The EAS provides the 
President with the capability to provide immediate communications and 
information to the general public at the national, state and local area 
level during periods of national emergency. The EAS also provides state 
and local governments and the National Weather Service with the 
capability to provide immediate communications and information to the 
general public concerning emergency situations posing a threat to life 
and property. State and local use of the EAS is required to be 
described in State EAS Plans that are administered by State Emergency 
Communications Committees (SECC) and submitted to the FCC for approval.
    In the Third Report and Order in EB Docket No. 04-296, FCC 11-12, 
the Commission adopted rules establishing a regulatory structure for a 
national test of the EAS. In order for the Commission to determine the 
extent to which the test, and by extension the EAS, was successful, the 
FCC adopted rules requiring EAS Participants, within forty five (45) 
days of the date of the first national EAS test, to record and submit 
to the Commission the following test-related diagnostic information for 
each alert received from each message source monitored at the time of 
the national test:
     Whether they received the alert message during the 
designated test;
     whether they retransmitted the alert;
     if they were not able to receive and/or transmit the 
alert, their `best effort' diagnostic analysis regarding the cause(s) 
for such failure;
     a description of their station identification and level of 
designation (PEP, LP-1, etc.);
     the date/time of receipt of the EAN message by all 
stations; the date/time of PEP station acknowledgement of receipt of 
the EAN message to FOC;
     the date/time of initiation of actual broadcast of the 
Presidential message;
     the date/time of receipt of the EAT message by all 
stations;
     who they were monitoring at the time of the test, and the 
make and
     model number of the EAS equipment that they utilized.
    The Third Report and Order indicates that the national tests of 
EAS, and related information collections will likely be carried out on 
an annual basis. On March 10, 2010, OMB approved the collection as 
indicated by the related Notice of Office of Management and Budget 
Action notification.
    The FCC is submitting this information collection to the Office of 
Management and Budget (OMB) as a revision of the previously approved 
information collection that established the mandatory Electronic Test 
Reporting System (ETRS) that EAS Participants must utilize to file 
identifying and test result data as part of their participation in 
nationwide EAS testing. Specifically, the Order adopted in EB Docket 
No. 04-296, FCC 16-32, amends the State EAS Plan filing requirements 
set forth at Section 11.21 of the Commission's rules to require EAS 
Participants (i.e., the broadcasters, cable systems, and other service 
providers subject to the FCC's EAS rules) to provide the following 
information to their respective SECC, who in turn will include such 
information in the State EAS Plan submitted to the Commission for 
approval:
     A description of any actions taken by the EAS Participant 
(acting individually, in conjunction with other EAS Participants in the 
geographic area, and/or in consultation with state and local emergency 
authorities), to make EAS alert content available in languages other 
than English to its non-English speaking audience(s);
     A description of any future actions planned by the EAS 
Participant, in consultation with state and local emergency 
authorities, to provide EAS alert content in languages other than 
English to its non-English speaking audience(s), along with an 
explanation for the EAS Participant's decision to plan or not plan such 
actions; and
     Any other relevant information that the EAS Participant 
may wish to provide.
    In addition, in the event that there is a material change to any of 
the information that EAS Participants are required to furnish their 
respective SECCs, EAS Participants must, within 60 days of the 
occurrence of such material change, submit aa letter to their 
respective SECCs, copying the Commission's Public Safety and Homeland 
Security Bureau (Bureau) that describe such change. The SECCs are 
required to incorporate the information in such letters as amendments 
to the State EAS Plans on file with the Bureau.
    This information will be used by FCC staff to gauge the 
effectiveness of the EAS's capacity to disseminate in-language EAS 
emergency alert content to persons who communicate in a language other 
than English or may have a limited understanding of the English 
language; to determine whether private and local efforts to disseminate 
EAS multilingual content might be incorporated into the overall 
national EAS structure; and to confirm that private and local EAS 
multilingual operations are consistent with national plans, FCC 
regulations, and EAS operation.
    The Commission expects that the costs to EAS Participants to comply 
with these reporting requirements will be minimal, and largely limited 
to internal administrative charges associated with drafting a brief 
statement, and submitting that statement, and any other relevant 
information that the EAS Participant may wish to provide to their SECC 
for inclusion into the State EAS Plan for the state in which the EAS 
Participant operates. The Commission further expects that the vast 
majority of EAS Participants are not engaged in multilingual EAS 
activities and therefore will need to submit nothing more than a very 
brief statement to their SECC explaining their decision to plan or not 
plan future actions to provide EAS alert content in languages other 
than English to their non-English speaking audience(s). For the 
presumably small percentage of EAS Participants that actually are 
engaged in multilingual EAS activities, the filing will merely require 
that they supply a summary of actions they already have taken in this 
regard. Accordingly, the FCC estimates that complying with the 
reporting requirement will take EAS Participants, on average, 
approximately one hour. The FCC estimates that compiling the EAS 
Participant summaries of multilingual EAS activities and incorporating 
such information into the State EAS Plan will take SECCs, on average, 
approximately 20 hours.
    The following information collection contained in part 11 may be 
impacted by these rule amendments: Section 11.21 requires that state 
and local EAS plans be reviewed and approved by the Chief, Public 
Safety and Homeland Security, prior to implementation to ensure that 
they are consistent with national plans, FCC regulations, and EAS 
operation.


[[Page 30540]]


Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2016-11583 Filed 5-16-16; 8:45 am]
 BILLING CODE 6712-01-P



                                                  30538                          Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices

                                                     On July 20, 2015, the Commission                     29, 2016; Technical Formulas for                      Act (PRA) of 1995 (44 U.S.C. 3501–
                                                  released the part 1 R&O in which it                     Competitive Bidding, Public Notice, 30                3520), the Federal Communications
                                                  updated many of its part 1 competitive                  FCC Rcd 11034, Appendix 3 (WTB                        Commission (FCC or the Commission)
                                                  bidding rules (See Updating Part 1                      2015); Wireless Telecommunications                    invites the general public and other
                                                  Competitive Bidding Rules; Expanding                    Bureau Releases Updated List of                       Federal agencies to take this
                                                  the Economic and Innovation                             Reserve-Eligible Nationwide Service                   opportunity to comment on the
                                                  Opportunities of Spectrum Through                       Providers in each PEA for the Broadcast               following information collection.
                                                  Incentive Auctions; Petition of                         Incentive Auction, Public Notice, AU                  Comments are requested concerning:
                                                  DIRECTV Group, Inc. and EchoStar LLC                    No. 14–252 (WTB 2016).                                Whether the proposed collection of
                                                  for Expedited Rulemaking to Amend                         The Commission seeks approval for                   information is necessary for the proper
                                                  Section 1.2105(a)(2)(xi) and 1.2106(a) of               revisions to its previously approved                  performance of the functions of the
                                                  the Commission’s Rules and/or for                       collection of information under OMB                   Commission, including whether the
                                                  Interim Conditional Waiver;                             Control Number 3060–0798 to permit                    information shall have practical utility;
                                                  Implementation of the Commercial                        the collection of the additional                      the accuracy of the Commission’s
                                                  Spectrum Enhancement Act and                            information for Commission licenses                   burden estimate; ways to enhance the
                                                  Modernization of the Commission’s                       and permits, pursuant to the rules and                quality, utility, and clarity of the
                                                  Competitive Bidding Rules and                           information collection requirements                   information collected; ways to minimize
                                                  Procedures, Report and Order, Order on                  adopted by the Commission in the Part                 the burden of the collection of
                                                  Reconsideration of the First Report and                 1 R&O and the Mobile Spectrum                         information on the respondents,
                                                  Order, Third Order on Reconsideration                   Holdings R&O. As part of the collection,              including the use of automated
                                                  of the Second Report and Order, and                     the Commission is seeking approval for                collection techniques or other forms of
                                                  Third Report and Order, FCC 15–80, 30                   the information collection and                        information technology; and ways to
                                                  FCC Rcd 7493 (2015), modified by                        recordkeeping requirements associated                 further reduce the information
                                                  Erratum, 30 FCC Rcd 8518 (2015) (Part                   with 47 CFR 1.2210(j), 1.2112(b)(2)(iii),             collection burden on small business
                                                  1 R&O)). Of relevance to the information                1.2112(b)(2)(v), 1.2112(b)(2)(vii), and               concerns with fewer than 25 employees.
                                                  collection at issue here, the                           1.2112(b)(2)(viii). Also, in certain                     The FCC may not conduct or sponsor
                                                  Commission: (1) Implemented a new                       circumstances, the Commission requires                a collection of information unless it
                                                  general prohibition on the filing of                    the applicant to provide copies of their              displays a currently valid control
                                                  auction applications by entities                        agreements and/or submit exhibits.                    number. No person shall be subject to
                                                  controlled by the same individual or set                  In addition, the Commission seeks                   any penalty for failing to comply with
                                                  of individuals (but with a limited                      approval for various other, non-                      a collection of information subject to the
                                                  exception for qualifying rural wireless                 substantive editorial/consistency edits               PRA that does not display a valid Office
                                                  partnerships); (2) modified the                         and updates to FCC Form 601 that                      of Management and Budget (OMB)
                                                  eligibility requirements for small                      correct inconsistent capitalization of                control number.
                                                  business benefits, and updated the                      words and other typographical errors,                 DATES: Written PRA comments should
                                                  standardized schedule of small business                 and better align the text on the form                 be submitted on or before July 18, 2016.
                                                  sizes, including the gross revenues                     with the text in the Commission rules                 If you anticipate that you will be
                                                  thresholds used to determine eligibility;               both generally and in connection with                 submitting comments, but find it
                                                  (3) established a new bidding credit for                recent non-substantive, organizational                difficult to do so within the period of
                                                  eligible rural service providers; (4)                   amendments to the Commission’s rules.                 time allowed by this notice, you should
                                                  adopted targeted attribution rules to                   The Commission therefore seeks                        advise the contact listed below as soon
                                                  prevent the unjust enrichment of                        approval for a revision to its currently              as possible.
                                                  ineligible entities; and (5) adopted rules              approved information collection on FCC                ADDRESSES: Direct all PRA comments to
                                                  prohibiting joint bidding arrangements                  Form 601 to revise FCC Form 601                       Nicole Ongele, FCC, via email PRA@
                                                  with limited exceptions. The updated                    accordingly.                                          fcc.gov and to Nicole.Ongele@fcc.gov.
                                                  Part 1 rules apply to applicants seeking                                                                      FOR FURTHER INFORMATION CONTACT: For
                                                                                                          Federal Communications Commission.
                                                  licenses and permits.                                                                                         additional information about the
                                                                                                          Marlene H. Dortch,
                                                     Additionally, on June 2, 2014 the                                                                          information collection, contact Nicole
                                                                                                          Secretary, Office of the Secretary.                   Ongele at (202) 418–2991.
                                                  Commission released the Mobile                          [FR Doc. 2016–11582 Filed 5–16–16; 8:45 am]
                                                  Spectrum Holdings R&O, in which the                                                                           SUPPLEMENTARY INFORMATION:
                                                  Commission updated its spectrum
                                                                                                          BILLING CODE 6712–01–P                                   OMB Control Number: 3060–0207.
                                                  screen and established rules for its                                                                             Title: Part 11—Emergency Alert
                                                  upcoming auctions of low-band                                                                                 System (EAS), Order, FCC 16–32.
                                                                                                          FEDERAL COMMUNICATIONS                                   Form Number: N/A.
                                                  spectrum. Of relevance to the                           COMMISSION                                               Type of Review: Revision of a
                                                  information collection at issue here, the                                                                     currently approved collection.
                                                  Commission stated that it could reserve                 [OMB 3060–0207]
                                                                                                                                                                   Respondents: Business or other for-
                                                  spectrum in order to ensure against                                                                           profit entities, not-for-profit institutions,
                                                                                                          Information Collection Being Reviewed
                                                  excessive concentration in holdings of                                                                        and state, local or tribal government.
                                                                                                          by the Federal Communications
                                                  below-1–GHz spectrum (In the Matter of                                                                           Number of Respondents and
                                                                                                          Commission
                                                  Policies Regarding Mobile Spectrum                                                                            Responses: 63,080 respondents;
                                                  Holdings, Expanding the Economic and
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                          AGENCY: Federal Communications                        3,596,546 responses.
                                                  Innovation Opportunities of Spectrum                    Commission.                                              Estimated Time per Response: 1 hour
                                                  Through Incentive Auctions, FCC 14–                     ACTION: Notice and request for                        (EAS Participants); 20 hours (SECCs).
                                                  63, Report and Order, 29 FCC Rcd 6133,                  comments.                                                Frequency of Response: One-time
                                                  90) 135 (2014) (Mobile Spectrum                                                                               reporting requirement and
                                                  Holdings R&O). See also Application                     SUMMARY:  As part of its continuing effort            recordkeeping requirement.
                                                  Procedures for Broadcast Incentive                      to reduce paperwork burdens, and as                      Obligation to Respond: Obligatory for
                                                  Auction Scheduled to Begin on March                     required by the Paperwork Reduction                   all entities required to participate in


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                                                                                 Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices                                            30539

                                                  EAS. Statutory authority for this                          • model number of the EAS                             This information will be used by FCC
                                                  collection of information is contained in               equipment that they utilized.                         staff to gauge the effectiveness of the
                                                  47 U.S.C. 154(i) and 606 of the                            The Third Report and Order indicates               EAS’s capacity to disseminate in-
                                                  Communications Act of 1934, as                          that the national tests of EAS, and                   language EAS emergency alert content
                                                  amended.                                                related information collections will                  to persons who communicate in a
                                                     Total Annual Burden: 110,476 hours.                  likely be carried out on an annual basis.             language other than English or may have
                                                     Total Annual Cost: No cost.                          On March 10, 2010, OMB approved the                   a limited understanding of the English
                                                     Privacy Impact Assessment: No                        collection as indicated by the related                language; to determine whether private
                                                  Impact(s).                                              Notice of Office of Management and
                                                     Nature and Extent of Confidentiality:                                                                      and local efforts to disseminate EAS
                                                                                                          Budget Action notification.
                                                  There is no need for confidentiality.                      The FCC is submitting this                         multilingual content might be
                                                     Needs and Uses: Part 11 contains                     information collection to the Office of               incorporated into the overall national
                                                  rules and regulations addressing the                    Management and Budget (OMB) as a                      EAS structure; and to confirm that
                                                  nation’s Emergency Alert System (EAS).                  revision of the previously approved                   private and local EAS multilingual
                                                  The EAS provides the President with                     information collection that established               operations are consistent with national
                                                  the capability to provide immediate                     the mandatory Electronic Test Reporting               plans, FCC regulations, and EAS
                                                  communications and information to the                   System (ETRS) that EAS Participants                   operation.
                                                  general public at the national, state and               must utilize to file identifying and test                The Commission expects that the
                                                  local area level during periods of                      result data as part of their participation            costs to EAS Participants to comply
                                                  national emergency. The EAS also                        in nationwide EAS testing. Specifically,              with these reporting requirements will
                                                  provides state and local governments                    the Order adopted in EB Docket No. 04–                be minimal, and largely limited to
                                                  and the National Weather Service with                   296, FCC 16–32, amends the State EAS                  internal administrative charges
                                                  the capability to provide immediate                     Plan filing requirements set forth at
                                                                                                                                                                associated with drafting a brief
                                                  communications and information to the                   Section 11.21 of the Commission’s rules
                                                                                                                                                                statement, and submitting that
                                                  general public concerning emergency                     to require EAS Participants (i.e., the
                                                                                                          broadcasters, cable systems, and other                statement, and any other relevant
                                                  situations posing a threat to life and
                                                                                                          service providers subject to the FCC’s                information that the EAS Participant
                                                  property. State and local use of the EAS
                                                  is required to be described in State EAS                EAS rules) to provide the following                   may wish to provide to their SECC for
                                                  Plans that are administered by State                    information to their respective SECC,                 inclusion into the State EAS Plan for the
                                                  Emergency Communications                                who in turn will include such                         state in which the EAS Participant
                                                  Committees (SECC) and submitted to                      information in the State EAS Plan                     operates. The Commission further
                                                  the FCC for approval.                                   submitted to the Commission for                       expects that the vast majority of EAS
                                                     In the Third Report and Order in EB                  approval:                                             Participants are not engaged in
                                                  Docket No. 04–296, FCC 11–12, the                          • A description of any actions taken               multilingual EAS activities and
                                                  Commission adopted rules establishing                   by the EAS Participant (acting                        therefore will need to submit nothing
                                                  a regulatory structure for a national test              individually, in conjunction with other               more than a very brief statement to their
                                                  of the EAS. In order for the Commission                 EAS Participants in the geographic area,              SECC explaining their decision to plan
                                                  to determine the extent to which the                    and/or in consultation with state and                 or not plan future actions to provide
                                                  test, and by extension the EAS, was                     local emergency authorities), to make                 EAS alert content in languages other
                                                  successful, the FCC adopted rules                       EAS alert content available in languages              than English to their non-English
                                                  requiring EAS Participants, within forty                other than English to its non-English                 speaking audience(s). For the
                                                  five (45) days of the date of the first                 speaking audience(s);                                 presumably small percentage of EAS
                                                  national EAS test, to record and submit                    • A description of any future actions
                                                                                                                                                                Participants that actually are engaged in
                                                  to the Commission the following test-                   planned by the EAS Participant, in
                                                                                                          consultation with state and local                     multilingual EAS activities, the filing
                                                  related diagnostic information for each                                                                       will merely require that they supply a
                                                  alert received from each message source                 emergency authorities, to provide EAS
                                                                                                          alert content in languages other than                 summary of actions they already have
                                                  monitored at the time of the national                                                                         taken in this regard. Accordingly, the
                                                  test:                                                   English to its non-English speaking
                                                                                                                                                                FCC estimates that complying with the
                                                     • Whether they received the alert                    audience(s), along with an explanation
                                                  message during the designated test;                     for the EAS Participant’s decision to                 reporting requirement will take EAS
                                                     • whether they retransmitted the                     plan or not plan such actions; and                    Participants, on average, approximately
                                                  alert;                                                     • Any other relevant information that              one hour. The FCC estimates that
                                                     • if they were not able to receive and/              the EAS Participant may wish to                       compiling the EAS Participant
                                                  or transmit the alert, their ‘best effort’              provide.                                              summaries of multilingual EAS
                                                  diagnostic analysis regarding the                          In addition, in the event that there is            activities and incorporating such
                                                  cause(s) for such failure;                              a material change to any of the                       information into the State EAS Plan will
                                                     • a description of their station                     information that EAS Participants are                 take SECCs, on average, approximately
                                                  identification and level of designation                 required to furnish their respective                  20 hours.
                                                  (PEP, LP–1, etc.);                                      SECCs, EAS Participants must, within
                                                                                                                                                                   The following information collection
                                                     • the date/time of receipt of the EAN                60 days of the occurrence of such
                                                                                                          material change, submit aa letter to their            contained in part 11 may be impacted
                                                  message by all stations; the date/time of
                                                                                                          respective SECCs, copying the                         by these rule amendments: Section
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  PEP station acknowledgement of receipt
                                                                                                          Commission’s Public Safety and                        11.21 requires that state and local EAS
                                                  of the EAN message to FOC;
                                                     • the date/time of initiation of actual              Homeland Security Bureau (Bureau)                     plans be reviewed and approved by the
                                                  broadcast of the Presidential message;                  that describe such change. The SECCs                  Chief, Public Safety and Homeland
                                                     • the date/time of receipt of the EAT                are required to incorporate the                       Security, prior to implementation to
                                                  message by all stations;                                information in such letters as                        ensure that they are consistent with
                                                     • who they were monitoring at the                    amendments to the State EAS Plans on                  national plans, FCC regulations, and
                                                  time of the test, and the make and                      file with the Bureau.                                 EAS operation.


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                                                  30540                          Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices

                                                  Federal Communications Commission.                        • If you want to submit a comment                   comments to public dockets, see 80 FR
                                                  Marlene H. Dortch,                                      with confidential information that you                56469, September 18, 2015, or access
                                                  Secretary.                                              do not wish to be made available to the               the information at: http://www.fda.gov/
                                                  [FR Doc. 2016–11583 Filed 5–16–16; 8:45 am]             public, submit the comment as a                       regulatoryinformation/dockets/
                                                  BILLING CODE 6712–01–P                                  written/paper submission and in the                   default.htm.
                                                                                                          manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                                                                          Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                  DEPARTMENT OF HEALTH AND                                Written/Paper Submissions                             electronic and written/paper comments
                                                  HUMAN SERVICES                                                                                                received, go to http://
                                                                                                             Submit written/paper submissions as                www.regulations.gov and insert the
                                                  Food and Drug Administration                            follows:                                              docket number, found in brackets in the
                                                                                                             • Mail/Hand deliveryCourier (for                   heading of this document, into the
                                                  [Docket No. FDA–2016–D–1224]                            written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                                                                                          Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                  Use of Electronic Health Record Data                    and Drug Administration, 5630 Fishers
                                                  in Clinical Investigations; Draft                                                                             Management, 5630 Fishers Lane, Rm.
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                  Guidance for Industry; Availability                        • For written/paper comments                          Submit written requests for single
                                                  AGENCY:    Food and Drug Administration,                submitted to the Division of Dockets                  copies of the draft guidance to the
                                                  HHS.                                                    Management, FDA will post your                        Division of Drug Information, Center for
                                                  ACTION:   Notice of availability.                       comment, as well as any attachments,
                                                                                                                                                                Drug Evaluation and Research, Food
                                                                                                          except for information submitted,
                                                                                                                                                                and Drug Administration, 10001 New
                                                  SUMMARY:   The Food and Drug                            marked and identified, as confidential,
                                                                                                                                                                Hampshire Ave., Hillandale Building,
                                                  Administration (FDA or Agency) is                       if submitted as detailed in
                                                                                                                                                                4th Floor, Silver Spring, MD 20993–
                                                  announcing the availability of a draft                  ‘‘Instructions.’’
                                                                                                             Instructions: All submissions received             0002; the Office of Communication,
                                                  guidance for industry entitled ‘‘Use of                                                                       Outreach, and Development, Center for
                                                  Electronic Health Record Data in                        must include the Docket No. FDA–
                                                                                                          2016–D–1224 for ‘‘Use of Electronic                   Biologics Evaluation and Research,
                                                  Clinical Investigations.’’ The draft
                                                                                                          Health Record Data in Clinical                        Food and Drug Administration, 10903
                                                  guidance is intended to assist sponsors,
                                                                                                          Investigations; Draft Guidance for                    New Hampshire Ave., Bldg. 71, Rm.
                                                  clinical investigators, contract research
                                                                                                          Industry; Availability.’’ Received                    3128, Silver Spring, MD 20993–0002; or
                                                  organizations, institutional review
                                                                                                          comments will be placed in the docket                 the Office of the Center Director,
                                                  boards (IRBs), and other interested
                                                                                                          and, except for those submitted as                    Guidance and Policy Development,
                                                  parties on the use of electronic health
                                                                                                          ‘‘Confidential Submissions,’’ publicly                Center for Devices and Radiological
                                                  record (EHR) data in FDA-regulated
                                                                                                          viewable at http://www.regulations.gov                Health, Food and Drug Administration,
                                                  clinical investigations.
                                                                                                          or at the Division of Dockets                         10903 New Hampshire Ave., Bldg. 66,
                                                  DATES: Although you can comment on
                                                                                                          Management between 9 a.m. and 4 p.m.,                 Rm. 5431, Silver Spring, MD 20993–
                                                  any guidance at any time (see 21 CFR                                                                          0002. Send one self-addressed adhesive
                                                  10.115(g)(5)), to ensure that the Agency                Monday through Friday.
                                                                                                             • Confidential Submissions—To                      label to assist that office in processing
                                                  considers your comment on this draft                                                                          your requests. See the SUPPLEMENTARY
                                                  guidance before it begins work on the                   submit a comment with confidential
                                                                                                          information that you do not wish to be                INFORMATION section for electronic
                                                  final version of the guidance, submit
                                                                                                          made publicly available, submit your                  access to the draft guidance document.
                                                  either electronic or written comments
                                                  on the draft guidance by July 18, 2016.                 comments only as a written/paper                      FOR FURTHER INFORMATION CONTACT:
                                                                                                          submission. You should submit two                     Cheryl Grandinetti, Center for Drug
                                                  ADDRESSES: You may submit comments
                                                  as follows:                                             copies total. One copy will include the               Evaluation and Research, Food and
                                                                                                          information you claim to be confidential              Drug Administration, 10903 New
                                                  Electronic Submissions                                  with a heading or cover note that states              Hampshire Ave., Bldg. 51, Rm. 3348,
                                                    Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                              Silver Spring, MD 20993–0002, 301–
                                                  following way:                                          CONFIDENTIAL INFORMATION.’’ The                       796–2500; Stephen Ripley, Center for
                                                    • Federal eRulemaking Portal: http://                 Agency will review this copy, including               Biologics Evaluation and Research,
                                                  www.regulations.gov. Follow the                         the claimed confidential information, in              Food and Drug Administration, 10903
                                                  instructions for submitting comments.                   its consideration of comments. The                    New Hampshire Ave., Bldg. 71, Rm.
                                                  Comments submitted electronically,                      second copy, which will have the                      7301, Silver Spring, MD 20993–0002,
                                                  including attachments, to http://                       claimed confidential information                      240–402–7911; or Irfan Khan, Center for
                                                  www.regulations.gov will be posted to                   redacted/blacked out, will be available               Devices and Radiological Health, Food
                                                  the docket unchanged. Because your                      for public viewing and posted on http://              and Drug Administration, 10903 New
                                                  comment will be made public, you are                    www.regulations.gov. Submit both                      Hampshire Ave., Bldg. 66, Rm. 3563,
                                                  solely responsible for ensuring that your               copies to the Division of Dockets                     Silver Spring, MD 20993–0002, 301–
                                                  comment does not include any                            Management. If you do not wish your                   796–7100.
                                                  confidential information that you or a                  name and contact information to be                    SUPPLEMENTARY INFORMATION:
                                                  third party may not wish to be posted,                  made publicly available, you can
                                                  such as medical information, your or                    provide this information on the cover                 I. Background
                                                  anyone else’s Social Security number, or                sheet and not in the body of your                        FDA is announcing the availability of
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  confidential business information, such                 comments and you must identify this                   a draft guidance for industry entitled
                                                  as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                  ‘‘Use of Electronic Health Record Data
                                                  that if you include your name, contact                  information marked as ‘‘confidential’’                in Clinical Investigations.’’ The draft
                                                  information, or other information that                  will not be disclosed except in                       guidance is intended to assist sponsors,
                                                  identifies you in the body of your                      accordance with 21 CFR 10.20 and other                clinical investigators, contract research
                                                  comments, that information will be                      applicable disclosure law. For more                   organizations, IRBs, and other interested
                                                  posted on http://www.regulations.gov.                   information about FDA’s posting of                    parties on the use of EHR data in FDA-


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Document Created: 2018-02-07 15:05:23
Document Modified: 2018-02-07 15:05:23
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 and request for comments.
DatesWritten PRA comments should be submitted on or before July 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
ContactFor additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
FR Citation81 FR 30538 

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