80_FR_61103 80 FR 60908 - Proposed Data Collection Submitted for Public Comment and Recommendations

80 FR 60908 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range60908-60909
FR Document2015-25648

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Ambulatory Medical Care Survey (NAMCS). The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States.

Federal Register, Volume 80 Issue 195 (Thursday, October 8, 2015)
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60908-60909]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25648]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0234; Docket No. CDC-2015-0086]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
revision of the National Ambulatory Medical Care Survey (NAMCS). The 
purpose of NAMCS is to meet the needs and demands for statistical 
information about the provision of ambulatory medical care services in 
the United States.

DATES: Written comments must be received on or before December 7, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0026 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    The National Ambulatory Medical Care Survey (NAMCS), (OMB No. 0920-
0234, expires 12/31/2017)--Revision -- National Center for Health 
Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 
242k), as amended, authorizes that the Secretary of Health and Human 
Services, acting through NCHS, shall collect statistics on the 
utilization of health care provided by non-federal office-based 
physicians in the United States. On December 19, 2014, the OMB approved 
data collection for three years from 2015 to 2017. This revision is to 
request approval to continue NAMCS data collection activities for three 
years from 2016-2018 and to add questions to the physician interview 
that pertain to policies, services, and experiences related to the 
prevention and treatment of sexually transmitted infections (STIs) and 
HIV prevention among adolescents and others. Small modifications will 
also be made to questions on the use of electronic health records. This 
notice also covers a decrease in the sample size resulting from smaller 
budget allocations. Due to this decrease, selected state estimates will 
not be available for 2016-2018 data.
    The National Ambulatory Medical Care Survey (NAMCS) has been 
conducted intermittently from 1973 through 1985, and annually since 
1989. The purpose of NAMCS, a voluntary survey, is to meet the needs 
and demands for statistical information about the provision of 
ambulatory medical care services in the United States. Ambulatory 
services are rendered in a wide variety of settings, including 
physicians' offices and hospital outpatient and emergency departments.
    The NAMCS target universe consists of all office visits made by 
ambulatory patients to non-Federal office-based physicians (excluding 
those in the specialties of anesthesiology, radiology, and pathology) 
who are engaged in direct patient care. In 2006, physicians and mid-
level providers (i.e., nurse practitioners, physician assistants, and 
nurse midwives) practicing in community health centers (CHCs) were 
added to the NAMCS sample, and these data will continue to be 
collected.
    To complement NAMCS data, NCHS initiated the National Hospital 
Ambulatory Medical Care Survey (NHAMCS, OMB No. 0920-0278, expires 02/
28/18) in 1992 to provide

[[Page 60909]]

data concerning patient visits to hospital outpatient and emergency 
departments. NAMCS and NHAMCS are the principal sources of data on 
ambulatory care provided in the United States.
    There is no cost to the respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Number of     Average burden      Total
              Type of respondents                                Form name                     Number of     responses per  per response (in    burden
                                                                                              respondents     respondent          hrs.)        (in hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Office-based physicians........................  Physician Induction Interview (NAMCS-1)..           2,590               1             45/60       1,943
                                                 Patient Record form (NAMCS-30) (Physician             259              30             14/60       1,813
                                                  abstracts).
                                                 Prepare and transmit EHR (MU On-Boarding)             130               1                 1         130
                                                 Pulling, refiling medical record forms              2,201              30              1/60       1,101
                                                  (FR abstracts).
Community Health Centers.......................  Induction Interview--service delivery                 104               1             30/60          52
                                                  site (NAMCS-201).
                                                 Induction Interview--Providers (NAMCS-1).             234               1             30/60         117
                                                 Patient Record form (NAMCS-30) (Provider               23              30             14/60         161
                                                  abstracts).
                                                 Pulling, refiling medical record forms                211              30              1/60         106
                                                  (FR abstracts).
Reabstraction study............................  Pulling, refiling medical record forms                 72              10              1/60          12
                                                  abstracts).
                                                                                           -------------------------------------------------------------
    Total......................................  .........................................  ..............  ..............  ................       5,435
--------------------------------------------------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-25648 Filed 10-7-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                  60908                        Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices

                                                  Leroy A. Richardson,                                    FOR FURTHER INFORMATION CONTACT:    To                Proposed Project
                                                  Chief, Information Collection Review Office,            request more information on the                         The National Ambulatory Medical
                                                  Office of Scientific Integrity, Office of the           proposed project or to obtain a copy of
                                                  Associate Director for Science, Office of the
                                                                                                                                                                Care Survey (NAMCS), (OMB No. 0920–
                                                                                                          the information collection plan and                   0234, expires 12/31/2017)—Revision —
                                                  Director, Centers for Disease Control and               instruments, contact the Information
                                                  Prevention.                                                                                                   National Center for Health Statistics
                                                                                                          Collection Review Office, Centers for                 (NCHS), Centers for Disease Control and
                                                  [FR Doc. 2015–25646 Filed 10–7–15; 8:45 am]
                                                                                                          Disease Control and Prevention, 1600                  Prevention (CDC).
                                                  BILLING CODE 4163–18–P                                  Clifton Road, NE., MS–D74, Atlanta,
                                                                                                          Georgia 30329; phone: 404–639–7570;                   Background and Brief Description
                                                                                                          Email: omb@cdc.gov.                                      Section 306 of the Public Health
                                                  DEPARTMENT OF HEALTH AND
                                                  HUMAN SERVICES                                          SUPPLEMENTARY INFORMATION:       Under the            Service (PHS) Act (42 U.S.C. 242k), as
                                                                                                          Paperwork Reduction Act of 1995 (PRA)                 amended, authorizes that the Secretary
                                                  Centers for Disease Control and                         (44 U.S.C. 3501–3520), Federal agencies               of Health and Human Services, acting
                                                  Prevention                                              must obtain approval from the Office of               through NCHS, shall collect statistics on
                                                                                                          Management and Budget (OMB) for each                  the utilization of health care provided
                                                  [60Day–16–0234; Docket No. CDC–2015–                    collection of information they conduct                by non-federal office-based physicians
                                                  0086]                                                   or sponsor. In addition, the PRA also                 in the United States. On December 19,
                                                                                                          requires Federal agencies to provide a                2014, the OMB approved data collection
                                                  Proposed Data Collection Submitted                                                                            for three years from 2015 to 2017. This
                                                  for Public Comment and                                  60-day notice in the Federal Register
                                                                                                          concerning each proposed collection of                revision is to request approval to
                                                  Recommendations                                                                                               continue NAMCS data collection
                                                                                                          information, including each new
                                                  AGENCY: Centers for Disease Control and                                                                       activities for three years from 2016–
                                                                                                          proposed collection, each proposed
                                                  Prevention (CDC), Department of Health                                                                        2018 and to add questions to the
                                                                                                          extension of existing collection of
                                                  and Human Services (HHS).                                                                                     physician interview that pertain to
                                                                                                          information, and each reinstatement of
                                                                                                                                                                policies, services, and experiences
                                                  ACTION: Notice with comment period.                     previously approved information
                                                                                                                                                                related to the prevention and treatment
                                                                                                          collection before submitting the
                                                  SUMMARY:   The Centers for Disease                                                                            of sexually transmitted infections (STIs)
                                                                                                          collection to OMB for approval. To
                                                  Control and Prevention (CDC), as part of                                                                      and HIV prevention among adolescents
                                                                                                          comply with this requirement, we are
                                                  its continuing efforts to reduce public                                                                       and others. Small modifications will
                                                                                                          publishing this notice of a proposed
                                                  burden and maximize the utility of                                                                            also be made to questions on the use of
                                                                                                          data collection as described below.
                                                  government information, invites the                                                                           electronic health records. This notice
                                                                                                             Comments are invited on: (a) Whether               also covers a decrease in the sample size
                                                  general public and other Federal
                                                                                                          the proposed collection of information                resulting from smaller budget
                                                  agencies to take this opportunity to
                                                                                                          is necessary for the proper performance               allocations. Due to this decrease,
                                                  comment on proposed and/or
                                                                                                          of the functions of the agency, including             selected state estimates will not be
                                                  continuing information collections, as
                                                  required by the Paperwork Reduction                     whether the information shall have                    available for 2016–2018 data.
                                                  Act of 1995. This notice invites                        practical utility; (b) the accuracy of the               The National Ambulatory Medical
                                                  comment on the proposed revision of                     agency’s estimate of the burden of the                Care Survey (NAMCS) has been
                                                  the National Ambulatory Medical Care                    proposed collection of information; (c)               conducted intermittently from 1973
                                                  Survey (NAMCS). The purpose of                          ways to enhance the quality, utility, and             through 1985, and annually since 1989.
                                                  NAMCS is to meet the needs and                          clarity of the information to be                      The purpose of NAMCS, a voluntary
                                                  demands for statistical information                     collected; (d) ways to minimize the                   survey, is to meet the needs and
                                                  about the provision of ambulatory                       burden of the collection of information               demands for statistical information
                                                  medical care services in the United                     on respondents, including through the                 about the provision of ambulatory
                                                  States.                                                 use of automated collection techniques                medical care services in the United
                                                                                                          or other forms of information                         States. Ambulatory services are
                                                  DATES:  Written comments must be                        technology; and (e) estimates of capital              rendered in a wide variety of settings,
                                                  received on or before December 7, 2015.                 or start-up costs and costs of operation,             including physicians’ offices and
                                                  ADDRESSES: You may submit comments,                     maintenance, and purchase of services                 hospital outpatient and emergency
                                                  identified by Docket No. CDC–2016–                      to provide information. Burden means                  departments.
                                                  0026 by any of the following methods:                   the total time, effort, or financial                     The NAMCS target universe consists
                                                    • Federal eRulemaking Portal:                         resources expended by persons to                      of all office visits made by ambulatory
                                                  Regulation.gov. Follow the instructions                 generate, maintain, retain, disclose or               patients to non-Federal office-based
                                                  for submitting comments.                                provide information to or for a Federal               physicians (excluding those in the
                                                    • Mail: Leroy A. Richardson,                          agency. This includes the time needed                 specialties of anesthesiology, radiology,
                                                  Information Collection Review Office,                   to review instructions; to develop,                   and pathology) who are engaged in
                                                  Centers for Disease Control and                         acquire, install and utilize technology               direct patient care. In 2006, physicians
                                                  Prevention, 1600 Clifton Road NE., MS–                  and systems for the purpose of                        and mid-level providers (i.e., nurse
                                                  D74, Atlanta, Georgia 30329.                            collecting, validating and verifying                  practitioners, physician assistants, and
                                                    Instructions: All submissions received                information, processing and                           nurse midwives) practicing in
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                                                  must include the agency name and                        maintaining information, and disclosing               community health centers (CHCs) were
                                                  Docket Number. All relevant comments                    and providing information; to train                   added to the NAMCS sample, and these
                                                  received will be posted without change                  personnel and to be able to respond to                data will continue to be collected.
                                                  to Regulations.gov, including any                       a collection of information, to search                   To complement NAMCS data, NCHS
                                                  personal information provided. For                      data sources, to complete and review                  initiated the National Hospital
                                                  access to the docket to read background                 the collection of information; and to                 Ambulatory Medical Care Survey
                                                  documents or comments received, go to                   transmit or otherwise disclose the                    (NHAMCS, OMB No. 0920–0278,
                                                  Regulations.gov.                                        information.                                          expires 02/28/18) in 1992 to provide


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                                                                                      Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices                                                                                                  60909

                                                  data concerning patient visits to                                       the principal sources of data on                                                There is no cost to the respondents
                                                  hospital outpatient and emergency                                       ambulatory care provided in the United                                        other than their time.
                                                  departments. NAMCS and NHAMCS are                                       States.

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

                                                  Office-based physicians             Physician Induction Interview (NAMCS–1) .............                                               2,590                            1                       45/60            1,943
                                                                                      Patient Record form (NAMCS–30) (Physician ab-                                                         259                           30                       14/60            1,813
                                                                                        stracts).
                                                                                      Prepare and transmit EHR (MU On-Boarding) .......                                                     130                            1                             1            130
                                                                                      Pulling, refiling medical record forms (FR ab-                                                      2,201                           30                          1/60          1,101
                                                                                        stracts).
                                                  Community Health                    Induction       Interview—service    delivery     site                                                 104                            1                      30/60                52
                                                    Centers.                            (NAMCS–201).
                                                                                      Induction Interview—Providers (NAMCS–1) ...........                                                   234                            1                        30/60             117
                                                                                      Patient Record form (NAMCS–30) (Provider ab-                                                           23                           30                        14/60             161
                                                                                        stracts).
                                                                                      Pulling, refiling medical record forms (FR ab-                                                         211                          30                          1/60            106
                                                                                        stracts).
                                                  Reabstraction study .....           Pulling, refiling medical record forms abstracts) .....                                                  72                         10                          1/60              12
                                                       Total ......................   ..................................................................................   ........................   ........................   ............................       5,435


                                                  Leroy A. Richardson,                                                    changes include new registration and                                          anyone else’s Social Security number, or
                                                  Chief, Information Collection Review Office,                            food process filing forms and a new                                           confidential business information, such
                                                  Office of Scientific Integrity, Office of the                           ‘‘smart form’’ system for electronic                                          as a manufacturing process. Please note
                                                  Associate Director for Science, Office of the                           submission of the process filing forms.                                       that if you include your name, contact
                                                  Director, Centers for Disease Control and                               Registration and process filing are                                           information, or other information that
                                                  Prevention.                                                             required by the AF and LACF                                                   identifies you in the body of your
                                                  [FR Doc. 2015–25648 Filed 10–7–15; 8:45 am]                             provisions of our regulations. This                                           comments, that information will be
                                                  BILLING CODE 4163–18–P                                                  guidance also provides general                                                posted on http://www.regulations.gov.
                                                                                                                          information about how to use FDA’s                                               • If you want to submit a comment
                                                                                                                          systems for electronic submission of the                                      with confidential information that you
                                                  DEPARTMENT OF HEALTH AND                                                applicable forms. In addition, this
                                                  HUMAN SERVICES                                                                                                                                        do not wish to be made available to the
                                                                                                                          guidance describes administrative                                             public, submit the comment as a
                                                  Food and Drug Administration                                            procedures for voluntary registration                                         written/paper submission and in the
                                                                                                                          and voluntary submissions when a                                              manner detailed (see ‘‘Written/Paper
                                                  [Docket No. FDA–2013–D–1622]                                            commercial processor has determined                                           Submissions’’ and ‘‘Instructions’’).
                                                                                                                          that its product is not an acidified food                                        Written/Paper Submissions: Submit
                                                  Submitting Food Canning                                                 or a low-acid canned food, and is
                                                  Establishment Registration Form and                                                                                                                   written/paper submissions as follows:
                                                                                                                          therefore not subject to our regulations
                                                  Food Process Filing Forms to the Food                                   for AF and LACF. Further, this guidance                                          • Mail/Hand delivery/Courier (for
                                                  and Drug Administration in Electronic                                   describes a voluntary process whereby,                                        written/paper submissions): Division of
                                                  or Paper Format: Guidance for                                           upon request, we review data and other                                        Dockets Management (HFA–305), Food
                                                  Industry; Availability                                                  information that relate to a new                                              and Drug Administration, 5630 Fishers
                                                                                                                          processing method or new equipment.                                           Lane, Rm. 1061, Rockville, MD 20852.
                                                  AGENCY:     Food and Drug Administration,
                                                  HHS.                                                                    DATES: Submit either electronic or                                               • For written/paper comments
                                                                                                                          written comments on FDA guidances at                                          submitted to the Division of Dockets
                                                  ACTION:    Notice.
                                                                                                                          any time.                                                                     Management, FDA will post your
                                                  SUMMARY:   The Food and Drug                                            ADDRESSES: You may submit comments                                            comment, as well as any attachments,
                                                  Administration (FDA or we) is                                           as follows:                                                                   except for information submitted,
                                                  announcing the availability of a                                           Electronic Submissions: Submit                                             marked and identified, as confidential,
                                                  guidance entitled ‘‘Submitting Form                                     electronic comments in the following                                          if submitted as detailed in
                                                  FDA 2541 (Food Canning Establishment                                    way:                                                                          ‘‘Instructions.’’
                                                  Registration) and Forms FDA 2541d,                                         • Federal eRulemaking Portal: http://                                         Instructions: All submissions received
                                                  FDA 2541e, FDA 2541f, and FDA 2541g                                     www.regulations.gov. Follow the                                               must include the Docket No. FDA–
                                                  (Food Process Filing Forms) to FDA in                                   instructions for submitting comments.                                         2013–D–1622 for Submitting Food
                                                  Electronic or Paper Format: Guidance                                    Comments submitted electronically,                                            Canning Establishment Registration
                                                  for Industry.’’ This guidance describes                                 including attachments, to http://                                             Form and Food Process Filing Forms to
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  the administrative procedures to be                                     www.regulations.gov will be posted to                                         the Food and Drug Administration in
                                                  used by commercial processors that                                      the docket unchanged. Because your                                            Electronic or Paper Format: Guidance
                                                  manufacture, process, or pack acidified                                 comment will be made public, you are                                          for Industry; Availability. Received
                                                  foods (‘‘AF’’) and/or thermally                                         solely responsible for ensuring that your                                     comments will be placed in the docket
                                                  processed low-acid foods packaged in                                    comment does not include any                                                  and, except for those submitted as
                                                  hermetically sealed containers                                          confidential information that you or a                                        ‘‘Confidential Submissions,’’ publicly
                                                  (historically referred to as ‘‘low-acid                                 third party may not wish to be posted,                                        viewable at http://www.regulations.gov
                                                  canned foods’’ or ‘‘LACF’’). These                                      such as medical information, your or                                          or at the Division of Dockets


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Document Created: 2015-12-15 08:42:29
Document Modified: 2015-12-15 08:42:29
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 with comment period.
DatesWritten comments must be received on or before December 7, 2015.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation80 FR 60908 

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