83_FR_31065 83 FR 30938 - Agency Forms Undergoing Paperwork Reduction Act Review

83 FR 30938 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 127 (July 2, 2018)

Page Range30938-30940
FR Document2018-14172

Federal Register, Volume 83 Issue 127 (Monday, July 2, 2018)
[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Pages 30938-30940]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18CV]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Rapid Response Suicide Investigation Data 
Collection to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on November 
9, 2017 to obtain comments from the public and affected agencies. CDC 
did not receive comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:

[[Page 30939]]

    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

Rapid Response Suicide Investigation Data Collection--New--National 
Center for Injury Prevention and Control (NCIPC), Centers for Disease 
Control and Prevention (CDC)

Background and Brief Description
    CDC is frequently called upon to respond to urgent requests from 
one or more external partners (e.g., local, state, territory, and 
tribal health authorities; other federal agencies; local and state 
leaders; schools; or other partner organizations) to conduct 
investigations of suicide. Supporting rapid investigations to inform 
the implementation of effective suicide prevention strategies is one of 
the most important ways CDC can serve to protect and promote the health 
of the public. Prior to this request, CDC had collected data for a 
suicide investigation via the OMB-approved Emergency Epidemic 
Investigations (EEI) ICR (OMB No. 0920-1011; expiration 3/31/2020), 
which supported data collections for Epi-Aid investigations. However, 
this mechanism is no longer available for rapid suicide responses due 
to the narrowing in scope of that generic. CDC requests approval for a 
3-year period for this Generic Information Collection Request to 
rapidly respond to urgent requests for CDC assistance to investigate an 
apparent and unexplained potential cluster or increase in suicidal 
behavior. Rapid Response Suicide Investigation Data Collections are 
specifically designed to inform the implementation of prevention 
strategies in a state, county, community, or vulnerable population 
where a possible suicide cluster or increasing trend has been observed. 
This generic clearance will not be used to conduct research studies or 
to collect data designed to draw conclusions about the United States or 
areas beyond the defined geographic location or vulnerable population 
that is the focus of the investigation.
    These public health data are used by external partners (e.g., 
local, state, territory, and tribal health authorities; other federal 
agencies; local and state leaders; schools; or other partner 
organizations) to identify, prioritize, and implement strategies to 
prevent suicidal behavior and suicide. Rapid Response Suicide 
Investigation Data Collections methods will vary and depend on the 
unique circumstances of the urgent and rapid response and objectives 
determined by CDC. Investigations may use descriptive and/or cohort- or 
case-control designs. Data collection modes may include: (a) Archival 
record abstraction; (b) face-to-face interview; (c) telephone 
interview; (d) web-based questionnaire; (e) self-administered 
questionnaire; and (f) focus groups. Multiple data collection designs 
and modes are likely to be employed in a single investigation. The 
subpopulation will vary and depend on the unique circumstances of the 
Rapid Response Suicide Investigation Data Collections. Requests for 
assistance may include a state, county, community, or vulnerable 
population. Suicide rates are increasing across age-groups and 
vulnerable populations, include, but are not limited to, youth, middle-
aged adults, active duty service personnel, veterans, and American 
Indian/Alaska Native communities. Investigations likely will often 
require collection of information from 10 or more respondents. The data 
analytic approach for the Rapid Response Suicide Investigation Data 
Collection will vary and depend on the objectives and methods of the 
investigation. Multiple analytical strategies are likely to be employed 
in a single investigation. This may include descriptive analyses, 
logistic regression, and temporal and spatial cluster analyses. The 
goal of the analyses is to inform suicide prevention strategies by 
understanding (a) significant increases in fatal or nonfatal suicidal 
behavior; (b) the risk factors associated with trends of fatal or 
nonfatal suicidal behavior; (c) the groups most affected (e.g., gender, 
age, location in community or state); and (d) current risk and 
protective factors and prevention opportunities. The total estimated 
annualized burden for this collection is 1,000 hours. The only cost to 
respondents will be time spent responding to the surveys.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Rapid Response Suicide Investigation    Rapid Response Suicide             2,000               1           30/60
 Data Collection Participants.           Investigation Data
                                         Collection Instruments.
----------------------------------------------------------------------------------------------------------------



[[Page 30940]]

Jeffrey M. Zirger,
Acting Chief, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2018-14172 Filed 6-29-18; 8:45 am]
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                                               30938                           Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices

                                               qualified candidates to apply to be                     to terms of either 2 or 4 years with the               information including name, return
                                               considered for appointment to the                       possibility of membership renewals as                  address, email address, and daytime
                                               Committee.                                              appropriate. Membership is limited to                  telephone number of the nominee and
                                               DATES:   Applicable: July 2, 2018.                      the specific individuals appointed and                 nominator. GSA will consider
                                                                                                       is non-transferrable. Members are                      nominations of all qualified individuals
                                               FOR FURTHER INFORMATION CONTACT:   Mr.
                                                                                                       expected to attend all meetings in                     to ensure that the Committee includes
                                               Ken Sandler, Office of Federal High-
                                                                                                       person, review all Committee materials,                the areas of high-performance building
                                               Performance Buildings, GSA, 202–219–
                                                                                                       and actively provide their advice and                  subject matter expertise needed. GSA
                                               1121.
                                                                                                       input on topics covered by the                         reserves the right to choose Committee
                                               SUPPLEMENTARY INFORMATION:                              Committee. Committee members will                      members based on qualifications,
                                               Background                                              not receive compensation or travel                     experience, Committee balance,
                                                                                                       reimbursements from the Government                     statutory requirements and all other
                                                  The Administrator of the GSA
                                                                                                       except where need has been                             factors deemed critical to the success of
                                               established the Green Building Advisory
                                                                                                       demonstrated and funds are available.                  the Committee. Candidates may be
                                               Committee (hereafter, ‘‘the Committee’’)                   Request for membership nominations:                 asked to provide detailed financial
                                               on June 20, 2011 (76 FR 118) pursuant                   This notice provides an opportunity for                information to permit evaluation of
                                               to Section 494 of the Energy                            individuals to present their                           potential conflicts of interest that could
                                               Independence and Security Act of 2007                   qualifications and apply for an open                   impede their work on the Committee, in
                                               (42 U.S.C. 17123, or EISA), in                          seat on the Committee. GSA will ask                    accordance with the requirements of
                                               accordance with the provisions of the                   Committee members whose terms are                      FACA. All nominations must be
                                               Federal Advisory Committee Act                          expiring to re-apply if they are                       submitted in sufficient time to be
                                               (FACA), as amended (5 U.S.C. App. 2).                   interested in continuing to serve on the               received by 5 p.m., Eastern Daylight
                                               Under this authority, the Committee                     Committee. GSA will review all                         Time (EDT), on Thursday, July 26, 2018,
                                               advises GSA on how the Office of                        applications and determine which                       and be addressed to ken.sandler@
                                               Federal High-Performance Buildings can                  candidates are likely to add the most                  gsa.gov.
                                               most effectively accomplish its mission.                value to the Committee based on the
                                               Extensive information about the                                                                                  Dated: June 27, 2018.
                                                                                                       criteria outlined in this notice.                      Kevin Kampschroer,
                                               Committee, including current members,                      At a minimum, prospective members
                                               is available on GSA’s website at http://                must have:                                             Federal Director, Office of Federal High-
                                               www.gsa.gov/gbac.                                                                                              Performance Buildings, Office of Government-
                                                  Membership requirements: The EISA                    —At least 5 years of high-performance                  wide Policy.
                                               statute authorizes the Committee and                       building experience, which may                      [FR Doc. 2018–14200 Filed 6–29–18; 8:45 am]
                                               identifies the categories of members to                    include a combination of project-                   BILLING CODE 6820–14–P
                                               be included. EISA names 10 federal                         based, research and policy
                                               agencies and offices to be represented                     experience.
                                               on the Committee, and GSA works                         —Academic degrees, certifications and/
                                               directly with these agencies to identify                   or training demonstrating high-                     DEPARTMENT OF HEALTH AND
                                               their qualified representatives. This                      performance building and related                    HUMAN SERVICES
                                               notice is focused exclusively on non-                      sustainability and real estate
                                                                                                          expertise.                                          Centers for Disease Control and
                                               federal members. EISA provides that, in                                                                        Prevention
                                               addition to its required federal                        —Knowledge of federal sustainability
                                               members, the Committee shall include                       and energy laws and programs.
                                                                                                       —Proven ability to work effectively in a               [30Day–18–18CV]
                                               ‘‘other relevant agencies and entities, as
                                               determined by the Federal Director.’’                      collaborative, multi-disciplinary
                                                                                                                                                              Agency Forms Undergoing Paperwork
                                               These are to include at least one                          environment and add value to the
                                                                                                                                                              Reduction Act Review
                                               representative of each of the following                    work of a committee.
                                                                                                       —Qualifications appropriate to specific                   In accordance with the Paperwork
                                               categories:
                                                  ‘‘(i) State and local governmental                      statutory requirements (listed above).              Reduction Act of 1995, the Centers for
                                               green building programs;                                   No person who is a federally-                       Disease Control and Prevention (CDC)
                                                  (ii) Independent green building                      registered lobbyist may serve on the                   has submitted the information
                                               associations or councils;                               Committee, in accordance with the                      collection request titled Rapid Response
                                                  (iii) Building experts, including                    Presidential Memorandum ‘‘Lobbyists                    Suicide Investigation Data Collection to
                                               architects, material suppliers, and                     on Agency Boards and Commissions’’                     the Office of Management and Budget
                                               construction contractors;                               (June 18, 2010).                                       (OMB) for review and approval. CDC
                                                  (iv) Security advisors focusing on                      Nomination process for Advisory                     previously published a ‘‘Proposed Data
                                               national security needs, natural                        Committee appointment: There is no                     Collection Submitted for Public
                                               disasters, and other dire emergency                     prescribed format for the nomination.                  Comment and Recommendations’’
                                               situations;                                             Individuals may nominate themselves                    notice on November 9, 2017 to obtain
                                                  (v) Public transportation industry                   or others. A nomination package shall                  comments from the public and affected
                                               experts; and                                            include the following information for                  agencies. CDC did not receive comments
                                                  (vi) Environmental health experts,                   each nominee: (1) A letter of nomination               related to the previous notice. This
                                               including those with experience in                      stating the name and organizational                    notice serves to allow an additional 30
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                                               children’s health.’’                                    affiliation(s) of the nominee,                         days for public and affected agency
                                                  EISA further specifies: ‘‘the total                  membership capacity he/she will serve                  comments.
                                               number of non-federal members on the                    (per statutory categories above),                         CDC will accept all comments for this
                                               Committee at any time shall not exceed                  nominee’s field(s) of expertise, and                   proposed information collection project.
                                               15.’’                                                   description of interest and                            The Office of Management and Budget
                                                  Member responsibilities: Approved                    qualifications; (2) A professional resume              is particularly interested in comments
                                               Committee members will be appointed                     or CV; and (3) Complete contact                        that:


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                                                                               Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices                                                30939

                                                 (a) Evaluate whether the proposed                     other federal agencies; local and state                unique circumstances of the urgent and
                                               collection of information is necessary                  leaders; schools; or other partner                     rapid response and objectives
                                               for the proper performance of the                       organizations) to conduct investigations               determined by CDC. Investigations may
                                               functions of the agency, including                      of suicide. Supporting rapid                           use descriptive and/or cohort- or case-
                                               whether the information will have                       investigations to inform the                           control designs. Data collection modes
                                               practical utility;                                      implementation of effective suicide                    may include: (a) Archival record
                                                 (b) Evaluate the accuracy of the                      prevention strategies is one of the most               abstraction; (b) face-to-face interview;
                                               agencies estimate of the burden of the                  important ways CDC can serve to                        (c) telephone interview; (d) web-based
                                               proposed collection of information,                     protect and promote the health of the                  questionnaire; (e) self-administered
                                               including the validity of the                           public. Prior to this request, CDC had                 questionnaire; and (f) focus groups.
                                               methodology and assumptions used;                       collected data for a suicide investigation             Multiple data collection designs and
                                                 (c) Enhance the quality, utility, and                 via the OMB-approved Emergency                         modes are likely to be employed in a
                                               clarity of the information to be                        Epidemic Investigations (EEI) ICR (OMB                 single investigation. The subpopulation
                                               collected;                                              No. 0920–1011; expiration 3/31/2020),                  will vary and depend on the unique
                                                 (d) Minimize the burden of the                        which supported data collections for                   circumstances of the Rapid Response
                                               collection of information on those who                  Epi-Aid investigations. However, this                  Suicide Investigation Data Collections.
                                               are to respond, including, through the                  mechanism is no longer available for                   Requests for assistance may include a
                                               use of appropriate automated,                           rapid suicide responses due to the                     state, county, community, or vulnerable
                                               electronic, mechanical, or other                        narrowing in scope of that generic. CDC                population. Suicide rates are increasing
                                               technological collection techniques or                  requests approval for a 3-year period for              across age-groups and vulnerable
                                               other forms of information technology,                  this Generic Information Collection                    populations, include, but are not limited
                                               e.g., permitting electronic submission of               Request to rapidly respond to urgent                   to, youth, middle-aged adults, active
                                               responses; and                                          requests for CDC assistance to
                                                 (e) Assess information collection                                                                            duty service personnel, veterans, and
                                                                                                       investigate an apparent and                            American Indian/Alaska Native
                                               costs.                                                  unexplained potential cluster or
                                                 To request additional information on                                                                         communities. Investigations likely will
                                                                                                       increase in suicidal behavior. Rapid                   often require collection of information
                                               the proposed project or to obtain a copy
                                                                                                       Response Suicide Investigation Data                    from 10 or more respondents. The data
                                               of the information collection plan and
                                                                                                       Collections are specifically designed to               analytic approach for the Rapid
                                               instruments, call (404) 639–7570 or
                                                                                                       inform the implementation of                           Response Suicide Investigation Data
                                               send an email to omb@cdc.gov. Direct
                                                                                                       prevention strategies in a state, county,              Collection will vary and depend on the
                                               written comments and/or suggestions
                                                                                                       community, or vulnerable population                    objectives and methods of the
                                               regarding the items contained in this
                                                                                                       where a possible suicide cluster or                    investigation. Multiple analytical
                                               notice to the Attention: CDC Desk
                                                                                                       increasing trend has been observed.                    strategies are likely to be employed in
                                               Officer, Office of Management and
                                                                                                       This generic clearance will not be used                a single investigation. This may include
                                               Budget, 725 17th Street NW,
                                                                                                       to conduct research studies or to collect              descriptive analyses, logistic regression,
                                               Washington, DC 20503 or by fax to (202)
                                                                                                       data designed to draw conclusions                      and temporal and spatial cluster
                                               395–5806. Provide written comments
                                                                                                       about the United States or areas beyond                analyses. The goal of the analyses is to
                                               within 30 days of notice publication.
                                                                                                       the defined geographic location or                     inform suicide prevention strategies by
                                               Proposed Project                                        vulnerable population that is the focus                understanding (a) significant increases
                                                                                                       of the investigation.                                  in fatal or nonfatal suicidal behavior; (b)
                                               Rapid Response Suicide Investigation
                                               Data Collection—New—National Center                       These public health data are used by                 the risk factors associated with trends of
                                               for Injury Prevention and Control                       external partners (e.g., local, state,                 fatal or nonfatal suicidal behavior; (c)
                                               (NCIPC), Centers for Disease Control                    territory, and tribal health authorities;              the groups most affected (e.g., gender,
                                               and Prevention (CDC)                                    other federal agencies; local and state                age, location in community or state);
                                                                                                       leaders; schools; or other partner                     and (d) current risk and protective
                                               Background and Brief Description                        organizations) to identify, prioritize, and            factors and prevention opportunities.
                                                 CDC is frequently called upon to                      implement strategies to prevent suicidal               The total estimated annualized burden
                                               respond to urgent requests from one or                  behavior and suicide. Rapid Response                   for this collection is 1,000 hours. The
                                               more external partners (e.g., local, state,             Suicide Investigation Data Collections                 only cost to respondents will be time
                                               territory, and tribal health authorities;               methods will vary and depend on the                    spent responding to the surveys.

                                                                                                      ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                 Average
                                                                                                                                                                                 Number of
                                                                                                                                                             Number of                         burden per
                                                            Type of respondents                                          Form name                                             responses per
                                                                                                                                                            respondents                         response
                                                                                                                                                                                 respondent     (in hours)

                                               Rapid Response Suicide Investigation Data              Rapid Response Suicide Investigation Data                       2,000                1          30/60
                                                 Collection Participants.                               Collection Instruments.
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                                               30940                           Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices

                                               Jeffrey M. Zirger,                                      the docket unchanged. Because your                     claimed confidential information
                                               Acting Chief, Office of Scientific Integrity,           comment will be made public, you are                   redacted/blacked out, will be available
                                               Office of the Associate Director for Science,           solely responsible for ensuring that your              for public viewing and posted on
                                               Office of the Director, Centers for Disease             comment does not include any                           https://www.regulations.gov. Submit
                                               Control and Prevention.                                 confidential information that you or a                 both copies to the Dockets Management
                                               [FR Doc. 2018–14172 Filed 6–29–18; 8:45 am]             third party may not wish to be posted,                 Staff. If you do not wish your name and
                                               BILLING CODE 4163–18–P                                  such as medical information, your or                   contact information to be made publicly
                                                                                                       anyone else’s Social Security number, or               available, you can provide this
                                                                                                       confidential business information, such                information on the cover sheet and not
                                               DEPARTMENT OF HEALTH AND                                as a manufacturing process. Please note                in the body of your comments and you
                                               HUMAN SERVICES                                          that if you include your name, contact                 must identify this information as
                                                                                                       information, or other information that                 ‘‘confidential.’’ Any information marked
                                               Food and Drug Administration                            identifies you in the body of your                     as ‘‘confidential’’ will not be disclosed
                                               [Docket No. FDA–2018–N–2027]                            comments, that information will be                     except in accordance with 21 CFR 10.20
                                                                                                       posted on https://www.regulations.gov.                 and other applicable disclosure law. For
                                               Agency Information Collection                             • If you want to submit a comment                    more information about FDA’s posting
                                               Activities; Proposed Collection;                        with confidential information that you                 of comments to public dockets, see 80
                                               Comment Request; Survey of Current                      do not wish to be made available to the                FR 56469, September 18, 2015, or access
                                               Manufacturing Practices for the                         public, submit the comment as a                        the information at: https://www.gpo.gov/
                                               Cosmetics Industry                                      written/paper submission and in the                    fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                                                                       manner detailed (see ‘‘Written/Paper                   23389.pdf.
                                               AGENCY:    Food and Drug Administration,                Submissions’’ and ‘‘Instructions’’).                      Docket: For access to the docket to
                                               HHS.
                                                                                                       Written/Paper Submissions                              read background documents or the
                                               ACTION:   Notice.                                                                                              electronic and written/paper comments
                                                                                                          Submit written/paper submissions as                 received, go to https://
                                               SUMMARY:    The Food and Drug                           follows:
                                               Administration (FDA, Agency, or we) is                                                                         www.regulations.gov and insert the
                                                                                                          • Mail/Hand delivery/Courier (for                   docket number, found in brackets in the
                                               announcing an opportunity for public                    written/paper submissions): Dockets
                                               comment on the proposed collection of                                                                          heading of this document, into the
                                                                                                       Management Staff (HFA–305), Food and                   ‘‘Search’’ box and follow the prompts
                                               certain information by the Agency.                      Drug Administration, 5630 Fishers
                                               Under the Paperwork Reduction Act of                                                                           and/or go to the Dockets Management
                                                                                                       Lane, Rm. 1061, Rockville, MD 20852.                   Staff, 5630 Fishers Lane, Rm. 1061,
                                               1995 (PRA), Federal Agencies are                           • For written/paper comments
                                               required to publish notice in the                                                                              Rockville, MD 20852.
                                                                                                       submitted to the Dockets Management
                                               Federal Register concerning each                                                                               FOR FURTHER INFORMATION CONTACT: Ila
                                                                                                       Staff, FDA will post your comment, as
                                               proposed collection of information and                  well as any attachments, except for                    S. Mizrachi, Office of Operations, Food
                                               to allow 60 days for public comment in                  information submitted, marked and                      and Drug Administration, Three White
                                               response to the notice. This notice                     identified, as confidential, if submitted              Flint North, 10A–12M, 11601
                                               solicits comments on a new information                  as detailed in ‘‘Instructions.’’                       Landsdown St., North Bethesda, MD
                                               collection: A survey of the cosmetics                      Instructions: All submissions received              20852, 301–796–7726, PRAStaff@
                                               industry on their current manufacturing                 must include the Docket No. FDA–                       fda.hhs.gov.
                                               practices.                                              2018–N–2027 for ‘‘Agency Information                   SUPPLEMENTARY INFORMATION: Under the
                                               DATES: Submit either electronic or                      Collection Activities; Proposed                        PRA (44 U.S.C. 3501–3520), Federal
                                               written comments on the collection of                   Collection; Comment Request; Survey of                 Agencies must obtain approval from the
                                               information by August 31, 2018.                         Current Manufacturing Practices for the                Office of Management and Budget
                                               ADDRESSES: You may submit comments                      Cosmetics Industry.’’ Received                         (OMB) for each collection of
                                               as follows. Please note that late,                      comments, those filed in a timely                      information they conduct or sponsor.
                                               untimely filed comments will not be                     manner (see ADDRESSES), will be placed                 ‘‘Collection of information’’ is defined
                                               considered. Electronic comments must                    in the docket and, except for those                    in 44 U.S.C. 3502(3) and 5 CFR
                                               be submitted on or before August 31,                    submitted as ‘‘Confidential                            1320.3(c) and includes Agency requests
                                               2018. The https://www.regulations.gov                   Submissions,’’ publicly viewable at                    or requirements that members of the
                                               electronic filing system will accept                    https://www.regulations.gov or at the                  public submit reports, keep records, or
                                               comments until midnight Eastern Time                    Dockets Management Staff between                       provide information to a third party.
                                               at the end of August 31, 2018.                          9 a.m. and 4 p.m., Monday through                      Section 3506(c)(2)(A) of the PRA (44
                                               Comments received by mail/hand                          Friday.                                                U.S.C. 3506(c)(2)(A)) requires Federal
                                               delivery/courier (for written/paper                        • Confidential Submissions—To                       Agencies to provide a 60-day notice in
                                               submissions) will be considered timely                  submit a comment with confidential                     the Federal Register concerning each
                                               if they are postmarked or the delivery                  information that you do not wish to be                 proposed collection of information
                                               service acceptance receipt is on or                     made publicly available, submit your                   before submitting the collection to OMB
                                               before that date.                                       comments only as a written/paper                       for approval. To comply with this
                                                                                                       submission. You should submit two                      requirement, FDA is publishing notice
                                               Electronic Submissions                                  copies total. One copy will include the                of the proposed collection of
                                                 Submit electronic comments in the                     information you claim to be confidential               information set forth in this document.
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                                               following way:                                          with a heading or cover note that states                  With respect to the following
                                                 • Federal eRulemaking Portal:                         ‘‘THIS DOCUMENT CONTAINS                               collection of information, FDA invites
                                               https://www.regulations.gov. Follow the                 CONFIDENTIAL INFORMATION.’’ The                        comments on these topics: (1) Whether
                                               instructions for submitting comments.                   Agency will review this copy, including                the proposed collection of information
                                               Comments submitted electronically,                      the claimed confidential information, in               is necessary for the proper performance
                                               including attachments, to https://                      its consideration of comments. The                     of FDA’s functions, including whether
                                               www.regulations.gov will be posted to                   second copy, which will have the                       the information will have practical


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Document Created: 2018-06-30 00:17:48
Document Modified: 2018-06-30 00:17:48
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
FR Citation83 FR 30938 

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