80_FR_36947 80 FR 36824 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System

80 FR 36824 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 123 (June 26, 2015)

Page Range36824-36825
FR Document2015-15641

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 123 (Friday, June 26, 2015)
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36824-36825]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15641]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Emergency Shortages 
Data Collection System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
27, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0491. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Emergency Shortages Data Collection System--(OMB Control Number 0910-
0491)--Extension

    Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized 
to implement general powers (including conducting research) to carry 
out effectively the mission of FDA. Subsequent to the events of 
September 11, 2001, and as part of broader counterterrorism and 
emergency preparedness activities, FDA's Center for Devices and 
Radiological Health (CDRH) began developing operational plans and 
interventions that would enable CDRH to anticipate and respond to 
medical device shortages that might arise in the context of Federally 
declared disasters/emergencies or regulatory actions. In particular, 
CDRH identified the need to acquire and maintain detailed data on 
domestic inventory, manufacturing capabilities, distribution plans, and 
raw material constraints for medical devices that would be in high 
demand, and/or would be vulnerable to shortages in specific disaster/
emergency situations or following specific regulatory actions. Such 
data could support prospective risk assessment, help inform risk 
mitigation strategies, and support real-time decision-making by the 
Department of Health and Human Services during actual emergencies or 
emergency preparedness exercises.
    FDA developed ``The Emergency Medical Device Shortages Program 
Survey'' in 2002 to support the acquisition of such data from medical 
device manufacturers. In 2004, CDRH changed the process for the data 
collection, and the electronic database in which the data were stored 
was formally renamed the ``Emergency Shortages Data Collection System'' 
(ESDCS). Recognizing that some of the data collected may be 
commercially confidential, access to the ESDCS is restricted to members 
of the CDRH Emergency Shortage Team (EST) and senior management with a 
need-to-know. At this time, the need-to-know senior management 
personnel are limited to two senior managers. Further, the data are 
used by this defined group only for decision making and planning in the 
context of a Federally declared disaster/emergency, an official 
emergency preparedness exercise, or a potential public health risk 
posed by non-disaster-related device shortage.
    The data procurement process consists of an initial scripted 
telephone call to a regulatory officer at a registered manufacturer of 
one or more key medical devices tracked in the ESDCS. In this initial 
call, the EST member describes the intent and goals of the data 
collection effort and makes the specific data request. After the 
initial call, one or more additional follow-up calls and/or electronic 
mail correspondence may be required to verify/validate data sent from 
the manufacturer, confirm receipt, and/or request additional detail. 
Although the regulatory officer is the agent who the EST member 
initially contacts, regulatory officers may designate an alternate 
representative within their organization to correspond subsequently 
with the CDRH EST member who is collecting or verifying/validating the 
data.
    Because of the dynamic nature of the medical device industry, 
particularly with respect to specific product lines, manufacturing 
capabilities, and raw material/subcomponent sourcing, it is necessary 
to update the data in the ESDCS at regular intervals. The EST makes 
such updates on a regular basis, but makes efforts to limit the 
frequency of outreach to a specific manufacturer to no more than every 
4 months.
    The ESDCS will only include those medical devices for which there 
will likely be high demand during a specific emergency/disaster, or for 
which there are sufficiently small numbers of manufacturers such that 
disruption of manufacture or loss of one or more of these manufacturers 
would create a shortage.
    In the Federal Register of March 18, 2015 (80 FR 14138), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Number of
           Activity/FD&C act section                  Number of          responses per         Total annual     Average burden  per      Total hours
                                                     respondents           respondent           responses             response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emergency Shortages Data Collection System                      125                    3                  375     0.5 (30 minutes)                  188
 (903(d)(2))...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 36825]]

    FDA based the burden estimates in Table 1 of this document on past 
experience with direct contact with the medical device manufacturers 
and anticipated changes in the medical device manufacturing patterns 
for the specific devices being monitored. FDA estimates that 
approximately 125 manufacturers would be contacted by telephone and/or 
electronic mail 3 times per year either to obtain primary data or to 
verify/validate data. Because the requested data represent data 
elements that are monitored or tracked by manufacturers as part of 
routine inventory management activities, it is anticipated that for 
most manufacturers, the estimated time required of manufacturers to 
complete the data request will not exceed 30 minutes per request cycle.

    Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15641 Filed 6-25-15; 8:45 am]
 BILLING CODE 4164-01-P



                                              36824                            Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices

                                                Dated: June 23, 2015.                                   Emergency Shortages Data Collection                    in the context of a Federally declared
                                              Leslie Kux,                                               System—(OMB Control Number 0910–                       disaster/emergency, an official
                                              Associate Commissioner for Policy.                        0491)—Extension                                        emergency preparedness exercise, or a
                                              [FR Doc. 2015–15711 Filed 6–25–15; 8:45 am]                  Under section 903(d)(2) of the Federal              potential public health risk posed by
                                              BILLING CODE 4164–01–P                                    Food, Drug, and Cosmetic Act (21 U.S.C.                non-disaster-related device shortage.
                                                                                                        393(d)(2)), the Commissioner of Food                      The data procurement process
                                                                                                        and Drugs is authorized to implement                   consists of an initial scripted telephone
                                              DEPARTMENT OF HEALTH AND                                  general powers (including conducting                   call to a regulatory officer at a registered
                                              HUMAN SERVICES                                            research) to carry out effectively the                 manufacturer of one or more key
                                                                                                        mission of FDA. Subsequent to the                      medical devices tracked in the ESDCS.
                                              Food and Drug Administration                              events of September 11, 2001, and as                   In this initial call, the EST member
                                              [Docket No. FDA–2012–N–0197]                              part of broader counterterrorism and                   describes the intent and goals of the
                                                                                                        emergency preparedness activities,                     data collection effort and makes the
                                              Agency Information Collection                             FDA’s Center for Devices and                           specific data request. After the initial
                                              Activities; Submission for Office of                      Radiological Health (CDRH) began                       call, one or more additional follow-up
                                              Management and Budget Review;                             developing operational plans and                       calls and/or electronic mail
                                              Comment Request; Emergency                                interventions that would enable CDRH                   correspondence may be required to
                                              Shortages Data Collection System                          to anticipate and respond to medical                   verify/validate data sent from the
                                                                                                        device shortages that might arise in the               manufacturer, confirm receipt, and/or
                                              AGENCY:      Food and Drug Administration,                context of Federally declared disasters/
                                              HHS.                                                                                                             request additional detail. Although the
                                                                                                        emergencies or regulatory actions. In                  regulatory officer is the agent who the
                                              ACTION:   Notice.                                         particular, CDRH identified the need to                EST member initially contacts,
                                              SUMMARY:   The Food and Drug                              acquire and maintain detailed data on                  regulatory officers may designate an
                                              Administration (FDA) is announcing                        domestic inventory, manufacturing                      alternate representative within their
                                              that a proposed collection of                             capabilities, distribution plans, and raw              organization to correspond subsequently
                                              information has been submitted to the                     material constraints for medical devices               with the CDRH EST member who is
                                              Office of Management and Budget                           that would be in high demand, and/or                   collecting or verifying/validating the
                                                                                                        would be vulnerable to shortages in                    data.
                                              (OMB) for review and clearance under
                                                                                                        specific disaster/emergency situations
                                              the Paperwork Reduction Act of 1995.                                                                                Because of the dynamic nature of the
                                                                                                        or following specific regulatory actions.
                                              DATES: Fax written comments on the                        Such data could support prospective                    medical device industry, particularly
                                              collection of information by July 27,                     risk assessment, help inform risk                      with respect to specific product lines,
                                              2015.                                                     mitigation strategies, and support real-               manufacturing capabilities, and raw
                                              ADDRESSES:   To ensure that comments on                   time decision-making by the                            material/subcomponent sourcing, it is
                                              the information collection are received,                  Department of Health and Human                         necessary to update the data in the
                                              OMB recommends that written                               Services during actual emergencies or                  ESDCS at regular intervals. The EST
                                              comments be faxed to the Office of                        emergency preparedness exercises.                      makes such updates on a regular basis,
                                              Information and Regulatory Affairs,                          FDA developed ‘‘The Emergency                       but makes efforts to limit the frequency
                                              OMB, Attn: FDA Desk Officer, FAX:                         Medical Device Shortages Program                       of outreach to a specific manufacturer to
                                              202–395–7285, or emailed to oira_                         Survey’’ in 2002 to support the                        no more than every 4 months.
                                              submission@omb.eop.gov. All                               acquisition of such data from medical                     The ESDCS will only include those
                                              comments should be identified with the                    device manufacturers. In 2004, CDRH                    medical devices for which there will
                                              OMB control number 0910–0491. Also                        changed the process for the data                       likely be high demand during a specific
                                              include the FDA docket number found                       collection, and the electronic database                emergency/disaster, or for which there
                                              in brackets in the heading of this                        in which the data were stored was                      are sufficiently small numbers of
                                              document.                                                 formally renamed the ‘‘Emergency                       manufacturers such that disruption of
                                                                                                        Shortages Data Collection System’’                     manufacture or loss of one or more of
                                              FOR FURTHER INFORMATION CONTACT:    FDA                   (ESDCS). Recognizing that some of the
                                              PRA Staff, Office of Operations, Food                                                                            these manufacturers would create a
                                                                                                        data collected may be commercially                     shortage.
                                              and Drug Administration, 8455                             confidential, access to the ESDCS is
                                              Colesville Rd., COLE–14526, Silver                        restricted to members of the CDRH                         In the Federal Register of March 18,
                                              Spring, MD 20993–0002, PRAStaff@                          Emergency Shortage Team (EST) and                      2015 (80 FR 14138), FDA published a
                                              fda.hhs.gov.                                              senior management with a need-to-                      60-day notice requesting public
                                              SUPPLEMENTARY INFORMATION:    In                          know. At this time, the need-to-know                   comment on the proposed collection of
                                              compliance with 44 U.S.C. 3507, FDA                       senior management personnel are                        information. No comments were
                                              has submitted the following proposed                      limited to two senior managers. Further,               received.
                                              collection of information to OMB for                      the data are used by this defined group                   FDA estimates the burden of this
                                              review and clearance.                                     only for decision making and planning                  collection of information as follows:

                                                                                              TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                      Number of
                                                                                              Number of                                         Total annual          Average burden
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                                                   Activity/FD&C act section                                        responses per                                                           Total hours
                                                                                             respondents                                         responses             per response
                                                                                                                      respondent

                                              Emergency Shortages Data Col-
                                               lection System (903(d)(2)) ........                125                       3                       375               0.5 (30 minutes)         188
                                                 1 There   are no capital costs or operating and maintenance costs associated with this collection of information.




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                                                                              Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices                                            36825

                                                 FDA based the burden estimates in                    DATES:   Written nominations for                       part of the comprehensive guidelines
                                              Table 1 of this document on past                        membership on the Committee must be                    supported by the Health Resources and
                                              experience with direct contact with the                 received on or before July 27, 2015.                   Services Administration. Pursuant to
                                              medical device manufacturers and                        ADDRESSES: Nomination packages must                    section 2713 of the Public Health
                                              anticipated changes in the medical                      be submitted electronically as email                   Service Act, codified at 42 U.S.C.
                                              device manufacturing patterns for the                   attachments to Ms. Lisa M. Vasquez,                    300gg–13, non-grandfathered health
                                              specific devices being monitored. FDA                   Genetic Services Branch, Maternal and                  plans and group and individual health
                                              estimates that approximately 125                        Child Health Bureau, Health Resources                  insurance issuers are required to cover
                                              manufacturers would be contacted by                     and Services Administration, lvasquez@                 screenings included in the HRSA-
                                              telephone and/or electronic mail 3 times                hrsa.gov.                                              supported comprehensive guidelines
                                              per year either to obtain primary data or               FOR FURTHER INFORMATION CONTACT: Ms.                   without charging a co-payment, co-
                                              to verify/validate data. Because the                    Lisa Vasquez, Genetic Services Branch,                 insurance, or deductible for plan years
                                              requested data represent data elements                  Maternal and Child Health Bureau,                      (i.e., in the individual market, policy
                                              that are monitored or tracked by                        HRSA, at lvasquez@hrsa.gov or (301)                    years) beginning on or after the date that
                                              manufacturers as part of routine                        443–4948. A copy of the Committee                      is 1 year from the Secretary’s adoption
                                              inventory management activities, it is                  Charter and list of the current                        of the condition for screening.
                                              anticipated that for most manufacturers,                membership can be obtained by                             Nominations: HRSA is requesting
                                              the estimated time required of                          accessing the Advisory Committee Web                   nominations to fill three (3) positions
                                              manufacturers to complete the data                      site at http://www.hrsa.gov/                           for voting members to serve on the
                                              request will not exceed 30 minutes per                  advisorycommittees/mchbadvisory/                       Committee. Nominations of potential
                                              request cycle.                                          heritabledisorders.                                    candidates for consideration are being
                                                                                                                                                             sought for individuals who are medical,
                                                Dated: June 22, 2015.                                 SUPPLEMENTARY INFORMATION: The                         technical, public health, or scientific
                                              Leslie Kux,                                             Committee is chartered under section                   professionals with special expertise in
                                              Associate Commissioner for Policy.                      1111 of the Public Health Service (PHS)                the field of heritable disorders or in
                                              [FR Doc. 2015–15641 Filed 6–25–15; 8:45 am]             Act, 42 U.S.C. 300b–10, as amended by                  providing screening, counseling, testing,
                                              BILLING CODE 4164–01–P
                                                                                                      the Newborn Screening Saves Lives                      or specialty services for newborns and
                                                                                                      Reauthorization Act of 2015 (Act). The                 children at risk for heritable disorders;
                                                                                                      Committee was established in 2003 to                   who have expertise in ethics (i.e.,
                                              DEPARTMENT OF HEALTH AND                                advise the Secretary of the U.S.                       bioethics) and infectious diseases and
                                              HUMAN SERVICES                                          Department of Health and Human                         who have worked and published
                                                                                                      Services regarding newborn screening                   material in the area of newborn
                                              Health Resources and Services                           tests, technologies, policies, guidelines,             screening; members of the public having
                                              Administration                                          and programs for effectively reducing                  special expertise about or concern with
                                                                                                      morbidity and mortality in newborns                    heritable disorders; or members from
                                              Advisory Committee on Heritable                         and children having or at risk for                     such federal agencies, public health
                                              Disorders in Newborns and Children                      heritable disorders. In addition, the                  constituencies, and medical
                                              Request for Nominations                                 Committee provides advice and                          professional societies as determined to
                                                                                                      recommendations to the Secretary                       be necessary by the Secretary. Interested
                                              AGENCY: Health Resources and Services
                                                                                                      concerning the grants and projects                     applicants may self-nominate or be
                                              Administration, HHS.
                                                                                                      authorized under section 1109 of the                   nominated by another individual and/or
                                              ACTION: Notice of request for                           PHS Act and technical information to                   organization.
                                              nominations.                                            develop policies and priorities for                       Individuals selected for appointment
                                                                                                      grants, including those that will                      to the Committee will be invited to
                                              SUMMARY:    The Health Resources and                    enhance the ability of the state and local             serve for up to 4 years. Members who
                                              Services Administration (HRSA) is                       health agencies to provide for newborn                 are not federal officers or permanent
                                              seeking nominations of qualified                        and child screening, counseling and                    federal employees are appointed as
                                              candidates to be considered for                         health care services for newborns, and                 special government employees and
                                              appointment as members of the                           children having or at risk for heritable               receive a stipend and reimbursement for
                                              Advisory Committee on Heritable                         disorders.                                             per diem and any travel expenses
                                              Disorders in Newborns and Children                         The Committee is governed by the                    incurred for attending Committee
                                              (Committee). The Committee provides                     provisions of Public Law 92–463, as                    meetings and/or conducting other
                                              advice, recommendations, and technical                  amended (5 U.S.C. App. 2), and 41 CFR                  business on behalf of the Committee, as
                                              information about aspects of heritable                  part 102–3, which set forth standards for              authorized by section 5 U.S.C. 5703 for
                                              disorders and newborn and childhood                     the formation and use of advisory                      persons employed intermittently in
                                              screening to the Secretary of Health and                committees. The Committee reviews                      government service. Members who are
                                              Human Services. HRSA is seeking                         and reports regularly on newborn and                   officers or employees of the United
                                              nominations of qualified candidates to                  childhood screening practices for                      States Government shall not receive
                                              fill three positions on the Committee.                  heritable disorders, recommends                        additional compensation for service on
                                                 Authority: Section 1111 of the Public                improvements in the national newborn                   the Committee, but receive per diem
                                              Health Service (PHS) Act, Title XI,                     and childhood heritable screening                      and travel expenses incurred for
                                              § 1111(g)(1) (42 U.S.C. 300b–10(g)(1)), as              programs, and recommends conditions                    attending Committee meetings and/or
                                              amended by the Newborn Screening Saves
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                      for inclusion in the Recommended                       conducting other business on behalf of
                                              Lives Reauthorization Act of 2014. The                  Uniform Screening Panel (RUSP). The
                                              Committee is governed by the Federal
                                                                                                                                                             the Committee. Nominees will be
                                              Advisory Committee Act (FACA), as
                                                                                                      Committee’s recommendations                            invited to serve during calendar year
                                              amended (5 U.S.C. App.), and 41 CFR part                regarding additional conditions/                       2016.
                                              102–3 and 41 CFR part 102–3, which set                  inherited disorders for screening that                    The following information must be
                                              forth standards for the formation and use of            have been adopted by the Secretary are                 included in the package of materials
                                              advisory committees.                                    included in the RUSP and constitute                    submitted for each individual being


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Document Created: 2015-12-15 14:14:39
Document Modified: 2015-12-15 14:14:39
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.
DatesFax written comments on the collection of information by July 27, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 36824 

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