82_FR_14270 82 FR 14219 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 14219 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 51 (March 17, 2017)

Page Range14219-14221
FR Document2017-05301

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 22, 2016 and allowed 60 days for public comment. Since AHRQ did not receive any substantive comments during this period, this notice allows for an additional 30 days for public comment.

Federal Register, Volume 82 Issue 51 (Friday, March 17, 2017)
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14219-14221]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05301]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) reapprove the information collection 
project: ``Consumer Assessment of Healthcare Providers and Systems 
(CAHPS) Health Plan Survey Comparative Database.'' In accordance with 
the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the 
public to comment on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on December 22, 2016 and allowed 60 days for 
public comment. Since AHRQ did not receive any substantive comments 
during this period, this notice allows for an additional 30 days for 
public comment.

DATES: Comments on this notice must be received by April 17, 2017.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at [email protected] (attention: AHRQ's desk officer).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health 
Plan Survey Comparative Database

    The Agency for Healthcare Research and Quality (AHRQ) requests that 
the Office of Management and Budget (OMB) reapprove, under the 
Paperwork

[[Page 14220]]

Reduction Act of 1995, AHRQ's collection of information for the AHRQ 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
Database for Health Plans: OMB Control number 0935-0165, expiration May 
31, 2017. The CAHPS Health Plan Database consists of data from the AHRQ 
CAHPS Health Plan Survey. Health plans in the U.S. are asked to submit 
data voluntarily from the survey to AHRQ through its contractor, 
Westat. The CAHPS Database was developed by AHRQ in 1998 in response to 
requests from health plans, purchasers, the Centers for Medicare and 
Medicaid Services (CMS) to provide comparative data to support public 
reporting of health plan ratings, health plan accreditation and quality 
improvement.
    This research has the following goals:
    (1) To maintain the CAHPS Health Plan database using data from 
AHRQ's standardized CAHPS Health Plan survey to provide comparative 
results to health care purchasers, consumers, regulators and policy 
makers across the country.
    (2) To offer several products and services, including comparative 
benchmark results presented through an Online Reporting System, summary 
chartbooks, custom analyses, and data for research purposes.
    (3) To provide data for AHRQ's annual National Healthcare Quality 
and Disparities Report.
    This study is being conducted by AHRQ through its contractor, 
Westat, pursuant to AHRQ's statutory authority to conduct and support 
research on health care and on systems for the delivery of such care, 
including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of health care services and with 
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) CAHPS Health Plan Survey that includes the Adult Medicaid, 
Child Medicaid and State Children's Health Insurance Program (SCHIP) 
populations. The Adult data collection uses the Adult survey and the 
Child and SCHIP collections include a child survey with chronic 
conditions and a child survey without chronic condition items. The 
CAHPS Health Plan surveys ask enrollees about their recent experiences 
with health plans and their services. This standardized survey was 
designed to support consumers in assessing the performance of health 
plans and choosing the plans that best meet their needs. Health plans 
can also use the survey results to identify their strengths and 
weaknesses and target areas for improvement. Participants have access 
to resources regarding the data submission process, a user guide and a 
technical assistance help line.
    (2) Medicare health plan data are received from CMS.
    Survey data from the CAHPS Health Plan Database is used to produce 
four types of products: (1) An annual chartbook available to the public 
on the CAHPS Database Web site (https://www.cahpsdatabase.ahrq.gov/CAHPSIDB/Public/Chartbook.aspx); (2) individual participant comparative 
reports that are confidential and customized for each participating 
organization (e.g., health plan, Medicaid agency) that submits their 
data; (3) a research database available to researchers wanting to 
conduct additional analyses; and (4) data tables provided to AHRQ for 
inclusion in the National Healthcare Quality and Disparities Report.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated burden hours for the respondent to 
participate in the database. The burden hours pertain only to the 
collection of Medicaid data from State Medicaid agencies and individual 
Medicaid health plans because those are the only entities that submit 
data through the data submission process (other data are obtained from 
CMS as noted earlier in Section 2). The 85 Point of Contact (POC)s in 
Exhibit 1 are a combination of an estimated 75 State Medicaid agencies 
and individual health plans, and 10 vendor organizations.
    Each State Medicaid agency, health plan or vendor will register 
online for submission. The online Registration form will require about 
5 minutes to complete. Each submitter will also complete a Health Plan 
information form of information about each Health Plan such as the name 
of the plan, the product type (e.g., HMO, PPO), the population surveyed 
(e.g., adult Medicaid or child Medicaid). Each year, the prior year's 
plan data are preloaded in the plan table to lessen burden on the 
Sponsor. The Sponsor is responsible for updating the plan table to 
reflect the current year's plan information. The online Health Plan 
Information form takes on average 30 minutes to complete per health 
plan with each POC completing the form for 4 plans on average. The data 
use agreement will be completed by the 75 participating State Medicaid 
agencies or individual health plans. Vendors do not sign or submit 
DUAs. The DUA requires about 3 minutes to sign and return by fax or 
mail. Each submitter will provide a copy of their questionnaire and the 
survey data file in the required file format. Survey data files must 
conform to the data file layout specifications provide by the CAHPS 
Database. Since the unit of analysis is at the health plan level, 
submitters will upload one data file per health plan. Once a data file 
is uploaded the file will be checked automatically to ensure it 
conforms to the specifications and a data file status report will be 
produced and made available to the submitter. Submitters will review 
each report and will be expected to fix any errors in their data file 
and resubmit if necessary. It will take about 1 hour to submit the data 
for each plan, and each POC will submit data for 4 plans on average. 
The total burden is estimated to be 501 hours annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of       Number of
                    Form name                      respondents/    responses per     Hours per     Total burden
                                                       POCs             POC          response          hours
----------------------------------------------------------------------------------------------------------------
Registration Form...............................              85               1            5/60               7
Health Plan Information Form....................              75               4           30/60             150
Data Use Agreement..............................              75               1            3/60               4
Data Files Submission...........................              85               4               1             340
                                                 ---------------------------------------------------------------
    Total.......................................             320              NA              NA             501
----------------------------------------------------------------------------------------------------------------


[[Page 14221]]

    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to complete one submission process. The cost burden 
is estimated to be $22,153 annually.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Registration Form...............................              85               7       \a\ 50.99            $357
Health Plan Information Form....................              75             150       \a\ 50.99           7,649
Data Use Agreement..............................              75               4       \b\ 89.35             357
Data Files Submission...........................              85             340       \c\ 40.56          13,790
                                                 ---------------------------------------------------------------
    Total.......................................             320             501              NA          22,153
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2015, ``U.S. Department of Labor,
  Bureau of Labor Statistics.''
\a\ Based on the mean hourly wage for Medical and Health Services Managers (11-9111).
\b\ Based on the mean hourly wage for Chief Executives (11-1011).
\c\ Based on the mean hourly wages for Computer Programmer (15-1131).

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ health care research and 
health care information dissemination functions, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-05301 Filed 3-16-17; 8:45 am]
BILLING CODE 4160-90-P



                                                                                    Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices                                                 14219

                                                    are in ‘‘Category 2.’’ In the FPL the                   of Engineers (USACE) to identify an                   Restoration Project Phase II, East McKay
                                                    Council approved approximately $156.6                   existing EA and associated                            Bay, Implementation.)
                                                    million in Category 1 restoration and                   environmental compliance
                                                                                                                                                                  Will D. Spoon,
                                                    planning activities, and prioritized                    documentation that could be used to
                                                    twelve Category 2 activities for possible                                                                     Program Analyst, Gulf Coast Ecosystem
                                                                                                            support Council approval of
                                                                                                                                                                  Restoration Council.
                                                    funding in the future, subject to                       implementation funding for Palm River.
                                                    environmental compliance and further                                                                          [FR Doc. 2017–05353 Filed 3–16–17; 8:45 am]
                                                                                                            This EA was prepared by USACE in
                                                    Council and public review. The Council                  association with a CWA Section 404                    BILLING CODE 6560–58–P

                                                    included planning activities for Palm                   nationwide permit (NWP 27) for aquatic
                                                    River in Category 1 and implementation                  habitat restoration, establishment and
                                                    activities for Palm River in Category 2.                enhancement activities.                               DEPARTMENT OF HEALTH AND
                                                       The Council reserved approximately                                                                         HUMAN SERVICES
                                                    $26.6 million for implementing priority                   The Council has reviewed this EA and
                                                    activities in the future. These reserved                associated documents, including a July                Agency for Healthcare Research and
                                                    funds may be used to support some, all                  31, 2014, USACE memorandum for the                    Quality
                                                    or none of the activities included in                   record documenting use of NWP 27 for
                                                    Category 2 of the FPL and/or to support                 Palm River and a February 22, 2017,                   Agency Information Collection
                                                    other activities not currently under                    U.S. Fish and Wildlife Service letter to              Activities: Proposed Collection;
                                                    consideration by the Council. As                        the Council regarding compliance with                 Comment Request
                                                    appropriate, the Council intends to                     the Endangered Species Act (ESA). In
                                                                                                                                                                  AGENCY: Agency for Healthcare Research
                                                    review each activity in Category 2 in                   addition to ESA, the EA and associated
                                                                                                                                                                  and Quality, HHS.
                                                    order to determine whether to: (1) Move                 documents address compliance with
                                                                                                            other Federal environmental laws,                     ACTION: Notice.
                                                    the activity to Category 1 and approve
                                                    it for funding, (2) remove it from                      including the Magnuson-Stevens                        SUMMARY:   This notice announces the
                                                    Category 2 and any further                              Fishery Conservation and Management                   intention of the Agency for Healthcare
                                                    consideration, or (3) continue to include               Act, the National Historic Preservation               Research and Quality (AHRQ) to request
                                                    it in Category 2. A Council decision to                 Act, and others. Based on this review,                that the Office of Management and
                                                    amend the FPL to move an activity from                  the Council is proposing to adopt this                Budget (OMB) reapprove the
                                                    Category 2 into Category 1 must be                      EA to support the approval of                         information collection project:
                                                    approved by a Council vote after                        implementation funds for Palm River,                  ‘‘Consumer Assessment of Healthcare
                                                    consideration of public and Tribal                      provided that the project is                          Providers and Systems (CAHPS) Health
                                                    comments.                                               implemented in accordance with the                    Plan Survey Comparative Database.’’ In
                                                                                                            terms and conditions of the CWA                       accordance with the Paperwork
                                                    II. Environmental Compliance
                                                                                                            Section 404 permit. This EA and the                   Reduction Act, 44 U.S.C. 3501–3521,
                                                       Prior to approving an activity for                   associated documentation can be found                 AHRQ invites the public to comment on
                                                    funding in FPL Category 1, the Council                  here: https://www.restorethegulf.gov/                 this proposed information collection.
                                                    must comply with NEPA and other                         funded-priorities-list. (See: Palm River                 This proposed information collection
                                                    applicable Federal environmental laws.                  Restoration Project Phase II, East McKay              was previously published in the Federal
                                                    At the time of approval of the FPL, the                 Bay—Implementation.)                                  Register on December 22, 2016 and
                                                    Council had not addressed NEPA and
                                                                                                            Palm River Project                                    allowed 60 days for public comment.
                                                    other laws applicable to implementation
                                                                                                                                                                  Since AHRQ did not receive any
                                                    of Palm River. The Council did,
                                                                                                              If approved for implementation                      substantive comments during this
                                                    however, recognize the potential
                                                                                                            funding, the Palm River project would                 period, this notice allows for an
                                                    ecological value of Palm River, based on
                                                                                                            entail construction of three stormwater               additional 30 days for public comment.
                                                    a review conducted during the FPL
                                                    process. For this reason, the Council                   ponds, exotic vegetation removal, native              DATES: Comments on this notice must be
                                                    approved $87,750 in planning funds for                  planting, monitoring, and perpetual                   received by April 17, 2017.
                                                    Palm River, a portion of which would be                 maintenance of exotic species and the                 ADDRESSES: Written comments should
                                                    used to complete any needed                             culverts/stormwater ponds along the                   be submitted to: AHRQ’s OMB Desk
                                                    environmental compliance activities. As                 Palm River at the mouth of McKay Bay.                 Officer by fax at (202) 395–6974
                                                    noted above, the Council placed the                     Specifically, the Palm River project                  (attention: AHRQ’s desk officer) or by
                                                    implementation portion of Palm River                    would improve water quality and                       email at OIRA_submission@
                                                    into FPL Category 2, pending the                        enhance upland and wetland areas on                   omb.eop.gov (attention: AHRQ’s desk
                                                    outcome of this environmental                           53 acres of Southwest Florida Water                   officer).
                                                    compliance work and further Council                     Management District land. It would
                                                                                                            remove exotic vegetation, create an                   FOR FURTHER INFORMATION CONTACT:
                                                    review. The estimated cost of                                                                                 Doris Lefkowitz, AHRQ Reports
                                                    implementation of the Florida portion of                herbaceous wetland, and build three
                                                                                                            stormwater management areas to                        Clearance Officer, (301) 427–1477, or by
                                                    Palm River is $497,250. As discussed                                                                          email at doris.lefkowitz@AHRQ.hhs.gov.
                                                    earlier, EPA sponsored another                          provide water quality treatment for 436
                                                                                                            acres of residential, commercial and                  SUPPLEMENTARY INFORMATION:
                                                    component of Palm River, which was
                                                    also placed in FPL Category 2. The                      industrial developed land.
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                  Proposed Project
                                                    estimated implementation cost of the                      Additional information on this
                                                                                                            Project, including metrics of success,                Consumer Assessment of Healthcare
                                                    EPA component is $271,430. As noted
                                                                                                            response to science reviews and more is               Providers and Systems (CAHPS) Health
                                                    above, the Council is proposing to unify
                                                                                                            available in an activity-specific                     Plan Survey Comparative Database
                                                    both components under one sponsor
                                                    (Florida).                                              appendix to the FPL, which can be                       The Agency for Healthcare Research
                                                       Since approval of the FPL, Florida,                  found at https://www.restorethegulf.gov.              and Quality (AHRQ) requests that the
                                                    EPA, and Council staff have                             (Please see the table on page 25 of the               Office of Management and Budget
                                                    collaborated with the U.S. Army Corps                   FPL and click on: Palm River                          (OMB) reapprove, under the Paperwork


                                               VerDate Sep<11>2014   20:02 Mar 16, 2017   Jkt 241001   PO 00000   Frm 00022   Fmt 4703   Sfmt 4703   E:\FR\FM\17MRN1.SGM   17MRN1


                                                    14220                                      Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices

                                                    Reduction Act of 1995, AHRQ’s                                               Medicaid and State Children’s Health                            (POC)s in Exhibit 1 are a combination of
                                                    collection of information for the AHRQ                                      Insurance Program (SCHIP) populations.                          an estimated 75 State Medicaid agencies
                                                    Consumer Assessment of Healthcare                                           The Adult data collection uses the                              and individual health plans, and 10
                                                    Providers and Systems (CAHPS)                                               Adult survey and the Child and SCHIP                            vendor organizations.
                                                    Database for Health Plans: OMB Control                                      collections include a child survey with                            Each State Medicaid agency, health
                                                    number 0935–0165, expiration May 31,                                        chronic conditions and a child survey
                                                                                                                                                                                                plan or vendor will register online for
                                                    2017. The CAHPS Health Plan Database                                        without chronic condition items. The
                                                    consists of data from the AHRQ CAHPS                                                                                                        submission. The online Registration
                                                                                                                                CAHPS Health Plan surveys ask
                                                    Health Plan Survey. Health plans in the                                     enrollees about their recent experiences                        form will require about 5 minutes to
                                                    U.S. are asked to submit data                                               with health plans and their services.                           complete. Each submitter will also
                                                    voluntarily from the survey to AHRQ                                         This standardized survey was designed                           complete a Health Plan information
                                                    through its contractor, Westat. The                                         to support consumers in assessing the                           form of information about each Health
                                                    CAHPS Database was developed by                                             performance of health plans and                                 Plan such as the name of the plan, the
                                                    AHRQ in 1998 in response to requests                                        choosing the plans that best meet their                         product type (e.g., HMO, PPO), the
                                                    from health plans, purchasers, the                                          needs. Health plans can also use the                            population surveyed (e.g., adult
                                                    Centers for Medicare and Medicaid                                           survey results to identify their strengths                      Medicaid or child Medicaid). Each year,
                                                    Services (CMS) to provide comparative                                       and weaknesses and target areas for                             the prior year’s plan data are preloaded
                                                    data to support public reporting of                                         improvement. Participants have access                           in the plan table to lessen burden on the
                                                    health plan ratings, health plan                                            to resources regarding the data                                 Sponsor. The Sponsor is responsible for
                                                    accreditation and quality improvement.                                      submission process, a user guide and a                          updating the plan table to reflect the
                                                       This research has the following goals:                                   technical assistance help line.                                 current year’s plan information. The
                                                       (1) To maintain the CAHPS Health                                           (2) Medicare health plan data are                             online Health Plan Information form
                                                    Plan database using data from AHRQ’s                                        received from CMS.                                              takes on average 30 minutes to complete
                                                    standardized CAHPS Health Plan survey                                         Survey data from the CAHPS Health                             per health plan with each POC
                                                    to provide comparative results to health                                    Plan Database is used to produce four                           completing the form for 4 plans on
                                                    care purchasers, consumers, regulators                                      types of products: (1) An annual                                average. The data use agreement will be
                                                    and policy makers across the country.                                       chartbook available to the public on the
                                                       (2) To offer several products and                                                                                                        completed by the 75 participating State
                                                                                                                                CAHPS Database Web site (https://                               Medicaid agencies or individual health
                                                    services, including comparative
                                                                                                                                www.cahpsdatabase.ahrq.gov/                                     plans. Vendors do not sign or submit
                                                    benchmark results presented through an
                                                                                                                                CAHPSIDB/Public/Chartbook.aspx); (2)                            DUAs. The DUA requires about 3
                                                    Online Reporting System, summary
                                                                                                                                individual participant comparative                              minutes to sign and return by fax or
                                                    chartbooks, custom analyses, and data
                                                                                                                                reports that are confidential and                               mail. Each submitter will provide a
                                                    for research purposes.
                                                       (3) To provide data for AHRQ’s                                           customized for each participating                               copy of their questionnaire and the
                                                    annual National Healthcare Quality and                                      organization (e.g., health plan, Medicaid                       survey data file in the required file
                                                    Disparities Report.                                                         agency) that submits their data; (3) a                          format. Survey data files must conform
                                                       This study is being conducted by                                         research database available to                                  to the data file layout specifications
                                                    AHRQ through its contractor, Westat,                                        researchers wanting to conduct                                  provide by the CAHPS Database. Since
                                                    pursuant to AHRQ’s statutory authority                                      additional analyses; and (4) data tables                        the unit of analysis is at the health plan
                                                    to conduct and support research on                                          provided to AHRQ for inclusion in the
                                                                                                                                                                                                level, submitters will upload one data
                                                    health care and on systems for the                                          National Healthcare Quality and
                                                                                                                                                                                                file per health plan. Once a data file is
                                                    delivery of such care, including                                            Disparities Report.
                                                                                                                                                                                                uploaded the file will be checked
                                                    activities with respect to the quality,                                     Estimated Annual Respondent Burden                              automatically to ensure it conforms to
                                                    effectiveness, efficiency,                                                                                                                  the specifications and a data file status
                                                    appropriateness and value of health care                                      Exhibit 1 shows the estimated burden
                                                                                                                                hours for the respondent to participate                         report will be produced and made
                                                    services and with respect to quality                                                                                                        available to the submitter. Submitters
                                                    measurement and improvement. 42                                             in the database. The burden hours
                                                                                                                                pertain only to the collection of                               will review each report and will be
                                                    U.S.C. 299a(a)(1) and (2).
                                                                                                                                Medicaid data from State Medicaid                               expected to fix any errors in their data
                                                    Method of Collection                                                        agencies and individual Medicaid                                file and resubmit if necessary. It will
                                                      To achieve the goals of this project the                                  health plans because those are the only                         take about 1 hour to submit the data for
                                                    following data collections will be                                          entities that submit data through the                           each plan, and each POC will submit
                                                    implemented:                                                                data submission process (other data are                         data for 4 plans on average. The total
                                                      (1) CAHPS Health Plan Survey that                                         obtained from CMS as noted earlier in                           burden is estimated to be 501 hours
                                                    includes the Adult Medicaid, Child                                          Section 2). The 85 Point of Contact                             annually.

                                                                                                                   EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                              Number of         Number of         Hours per     Total burden
                                                                                                     Form name                                                               respondents/     responses per       response         hours
                                                                                                                                                                                POCs              POC
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Registration Form ............................................................................................                       85                1             5/60              7
                                                    Health Plan Information Form .........................................................................                               75                4            30/60            150
                                                    Data Use Agreement .......................................................................................                           75                1             3/60              4
                                                    Data Files Submission .....................................................................................                          85                4                1            340

                                                          Total ..........................................................................................................              320               NA              NA             501




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                                                                                               Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices                                                                 14221

                                                      Exhibit 2 shows the estimated                                             submission process. The cost burden is
                                                    annualized cost burden based on the                                         estimated to be $22,153 annually.
                                                    respondents’ time to complete one

                                                                                                                    EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                                                                    Average
                                                                                                                                                                              Number of       Total burden                        Total cost
                                                                                                     Form name                                                                                                    hourly wage
                                                                                                                                                                             respondents         hours                             burden
                                                                                                                                                                                                                     rate *

                                                    Registration Form ............................................................................................                       85                7            a 50.99         $357
                                                    Health Plan Information Form .........................................................................                               75              150            a 50.99         7,649
                                                    Data Use Agreement .......................................................................................                           75                4            b 89.35           357
                                                    Data Files Submission .....................................................................................                          85              340            c 40.56        13,790

                                                          Total ..........................................................................................................              320              501               NA          22,153
                                                       * National Compensation Survey: Occupational wages in the United States May 2015, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
                                                       a Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
                                                       b Based on the mean hourly wage for Chief Executives (11–1011).
                                                       c Based on the mean hourly wages for Computer Programmer (15–1131).




                                                    Request for Comments                                                        DEPARTMENT OF HEALTH AND                                        www.regulations.gov will be posted to
                                                                                                                                HUMAN SERVICES                                                  the docket unchanged. Because your
                                                      In accordance with the Paperwork                                                                                                          comment will be made public, you are
                                                    Reduction Act, comments on AHRQ’s                                           Food and Drug Administration                                    solely responsible for ensuring that your
                                                    information collection are requested                                                                                                        comment does not include any
                                                    with regard to any of the following: (a)                                    [Docket No. FDA–2010–N–0536]
                                                                                                                                                                                                confidential information that you or a
                                                    Whether the proposed collection of                                          Agency Information Collection                                   third party may not wish to be posted,
                                                    information is necessary for the proper                                     Activities; Proposed Collection;                                such as medical information, your or
                                                    performance of AHRQ health care                                             Comment Request; Guidance for                                   anyone else’s Social Security number, or
                                                    research and health care information                                        Industry on Pharmacogenomic Data                                confidential business information, such
                                                    dissemination functions, including                                          Submissions                                                     as a manufacturing process. Please note
                                                    whether the information will have                                                                                                           that if you include your name, contact
                                                    practical utility; (b) the accuracy of                                      AGENCY:        Food and Drug Administration,                    information, or other information that
                                                    AHRQ’s estimate of burden (including                                        HHS.                                                            identifies you in the body of your
                                                    hours and costs) of the proposed                                            ACTION:       Notice.                                           comments, that information will be
                                                    collection(s) of information; (c) ways to                                                                                                   posted on https://www.regulations.gov.
                                                                                                                                SUMMARY:   The Food and Drug                                      • If you want to submit a comment
                                                    enhance the quality, utility, and clarity
                                                                                                                                Administration (FDA, Agency, or we) is                          with confidential information that you
                                                    of the information to be collected; and                                                                                                     do not wish to be made available to the
                                                                                                                                announcing an opportunity for public
                                                    (d) ways to minimize the burden of the                                                                                                      public, submit the comment as a
                                                                                                                                comment on the proposed collection of
                                                    collection of information upon the                                          certain information by the Agency.                              written/paper submission and in the
                                                    respondents, including the use of                                           Under the Paperwork Reduction Act of                            manner detailed (see ‘‘Written/Paper
                                                    automated collection techniques or                                          1995 (the PRA), Federal Agencies are                            Submissions’’ and ‘‘Instructions’’).
                                                    other forms of information technology.                                      required to publish notice in the                               Written/Paper Submissions
                                                      Comments submitted in response to                                         Federal Register concerning each
                                                    this notice will be summarized and                                          proposed collection of information,                                Submit written/paper submissions as
                                                    included in the Agency’s subsequent                                         including each proposed extension of an                         follows:
                                                                                                                                existing collection of information, and                            • Mail/Hand delivery/Courier (for
                                                    request for OMB approval of the                                                                                                             written/paper submissions): Division of
                                                    proposed information collection. All                                        to allow 60 days for public comment in
                                                                                                                                response to the notice. This notice                             Dockets Management (HFA–305), Food
                                                    comments will become a matter of                                                                                                            and Drug Administration, 5630 Fishers
                                                    public record.                                                              solicits comments on the information
                                                                                                                                collection resulting from the submission                        Lane, Rm. 1061, Rockville, MD 20852.
                                                    Sharon B. Arnold,                                                                                                                              • For written/paper comments
                                                                                                                                to the Agency of pharmacogenomic data
                                                                                                                                                                                                submitted to the Division of Dockets
                                                    Acting Director.                                                            during the drug development process.
                                                                                                                                                                                                Management, FDA will post your
                                                    [FR Doc. 2017–05301 Filed 3–16–17; 8:45 am]                                 DATES: Submit either electronic or                              comment, as well as any attachments,
                                                    BILLING CODE 4160–90–P                                                      written comments on the collection of                           except for information submitted,
                                                                                                                                information by May 16, 2017.                                    marked and identified, as confidential,
                                                                                                                                ADDRESSES: You may submit comments                              if submitted as detailed in
                                                                                                                                as follows:                                                     ‘‘Instructions.’’
                                                                                                                                                                                                   Instructions: All submissions received
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                Electronic Submissions                                          must include the Docket No. FDA–
                                                                                                                                  Submit electronic comments in the                             2010–N–0536 for ‘‘Guidance for
                                                                                                                                following way:                                                  Industry on Pharmacogenomic Data
                                                                                                                                  • Federal eRulemaking Portal:                                 Submissions.’’ Received comments will
                                                                                                                                https://www.regulations.gov. Follow the                         be placed in the docket and, except for
                                                                                                                                instructions for submitting comments.                           those submitted as ‘‘Confidential
                                                                                                                                Comments submitted electronically,                              Submissions,’’ publicly viewable at
                                                                                                                                including attachments, to https://                              https://www.regulations.gov or at the


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Document Created: 2017-03-17 02:49:15
Document Modified: 2017-03-17 02:49:15
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.
DatesComments on this notice must be received by April 17, 2017.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation82 FR 14219 

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