Agency Information Collection Activities: Proposed Collection; Comment Request, 27779-27781 [2019-12606]

Download as PDF Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices Dated at Washington, DC, on June 11, 2019. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. 2019–12553 Filed 6–13–19; 8:45 am] BILLING CODE 6714–01–P DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION A. Solicitation of Public Comment NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000–0114; Docket No. 2019–0003; Sequence No. 9] Information Collection; Right of First Refusal of Employment Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA). ACTION: Notice of request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, the FAR Council invites the public to comment upon a renewal concerning right of first refusal employment. DATES: Submit comments on or before August 13, 2019. ADDRESSES: The FAR Council invites interested persons to submit comments on this collection by either of the following methods: • Federal eRulemaking Portal: This website provides the ability to type short comments directly into the comment field or attach a file for lengthier comments. Go to http:// www.regulations.gov and follow the instructions on the site. • Mail: General Services Administration, Regulatory Secretariat Divison (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 9000–0114, Right of First Refusal of Employment. Instructions: Please submit comments only and cite Information Collection 9000–0114, Right of First Refusal of Employment, in all correspondence related to this collection. Comments received generally will be posted without change to http:// www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:24 Jun 13, 2019 Jkt 247001 check www.regulations.gov, approximately two-to-three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). FOR FURTHER INFORMATION CONTACT: Mr. Michael O. Jackson, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, at 202–208– 4949 or via email at michaelo.jackson@ gsa.gov. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public should address one or more of the following four points: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. B. Purpose As prescribed in FAR 7.305(c), the clause at FAR 52.207–3, Right of First Refusal of Employment, deals with adversely affected or separated Government employees resulting from the conversion of work from in-house performance to performance by contract. The clause requires the contractor to give these employees an opportunity to work for the contractor who is awarded the contract. The information gathered will be used by the Government to gain knowledge of which employees, adversely affected or separated as a result of the contract award, have gained employment with the contractor within 90 days after contract performance begins. C. Annual Reporting Burden Number of Respondents: 10. Responses per Respondent: 1. Total Responses: 10. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 27779 Hours per Response: 3. Total Burden Hours: 30. Frequency of Collection: On occasion. Affected Public: Businesses or other for-profit and not-for profit organizations. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000– 0114, Right of First Refusal of Employment, in all correspondence. Dated: June 7, 2019. Janet Fry, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2019–12570 Filed 6–13–19; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ‘‘Systematic Review Data Repository.’’ In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. DATES: Comments on this notice must be received on or before 60 days after date of publication. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. SUMMARY: E:\FR\FM\14JNN1.SGM 14JNN1 27780 Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by emails at doris.lefkowitz@ AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Proposed Project Systematic Review Data Repository (SRDR) In 1997, AHRQ launched an initiative to promote evidence-based practice in everyday care through establishment of the Evidence-based Practice Center (EPC) Program. Since then, the EPCs have been reviewing all relevant scientific literature on a wide spectrum of clinical and health services topics to produce various types of evidence reports. A majority of these evidence reports are systematic reviews (SRs), which are used as evidence bases for clinical practice guidelines, research agendas, healthcare coverage, and other health related policies. Performing SRs is costly in time, labor, and money. Moreover, there is an increasing expectation of quicker turnaround in producing SRs to accommodate the fast moving pace of innovations and new scientific discoveries in healthcare. Some SRs overlap or are replicated; independent teams of SR producers often extract data from the same studies, resulting in replication of work. Current methodology makes it difficult to harness and reuse previous work when updating SRs. In an effort to reduce the economic burden of conducting SRs, the EPC Program undertook development of a collaborative, Web-based repository of systematic review data called the Systematic Review Data Repository (SRDR). This resource serves as both an archive and data extraction tool, shared among organizations and individuals producing SRs worldwide, enabling the creation of a central database of SR data. This database is collaboratively vetted, freely accessible, and integrates seamlessly with reviewers’ existing workflows, with the ultimate goal of facilitating the efficient generation and update of evidence reviews, and thus speeding and improving policy-making with regards to health care. Currently, there are two versions of the database: (1) The original version called ‘‘SRDR’’; and (2) an upgraded version with increased functionality. Further upgrade of the database is planned for the next year (to be called ‘‘SRDR 2.0’’). The SRDR project encompasses the various iterations of the database. The SRDR project aims to achieve the following goals: (1) Create online easy-to-use Webbased tools for conducting systematic reviews to facilitate extraction of data from primary studies; (2) Develop an open-access searchable archive of key questions addressed in systematic reviews; (3) Maintain a public repository of primary study data including provision of technical support for repository users; and (4) Develop a process for making summary data from systematic reviews digitally shareable to end-users. This study is being conducted by AHRQ through its contractor, Brown University, 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 healthcare services, including database development. 42 U.S.C 299a(a)(1) and (8). Method of Collection To achieve the goals of this project the following data collections will be implemented: (1) Collect registration data and information on SRs from SR producers who will populate the SRDR system. SRDR uses a three-tiered categorization of users and collection of registration data that depends on the type of user: (1) ‘‘Contributors’’ are SR producers who use SRDR as a tool to support production of the SR and share scientific data from their SRs. Registration data will be collected from these users; (2) ‘‘Commentators’’ provide comments (i.e. opinions) on publicly available scientific data in SRDR. Registration data will be collected from these users; (3) ‘‘General public’’ users only view scientific data publicly available in SRDR. No data will be collected from these type of users. All Contributors and Commentators will undergo a simple self-registration process by providing a username, password, email address, and institution. Collection of registration data from Contributors and Commentators is required due to the use of SRDR both as a database and as a tool for assisting in the production of a SR, including providing comments in the various sections of a particular project on SRDR. In addition, provision of an email address and institution information allows the administrators of SRDR to confirm that requests are being made by actual people and not potentially malicious software code such as bots and other cybersecurity threats. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents’ time to participate in the SRDR. In 2017, 176 users registered as Commentators and 206 users registered as Contributors. Registration will take approximately 2 minutes per user. We thus calculate the total burden hours required for registration for all users annually is 12.73 hours. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents jbell on DSK3GLQ082PROD with NOTICES Form name Number of responses per respondent Hours per response Total burden hours Registration of users as Commentators or Contributors ......................... 382 1 2/60 12.73 Total .................................................................................................. 382 .......................... .......................... 12.73 Exhibit 2 shows the estimated cost burden associated with the respondents’ VerDate Sep<11>2014 17:04 Jun 13, 2019 Jkt 247001 time to participate in the SRDR. The total cost burden to respondents is PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 estimated at an average of $501.82 annually. E:\FR\FM\14JNN1.SGM 14JNN1 27781 Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden Registration of users as Commentators or Contributors ......................... 382 12.73 a $39.42 $501.82 Total .................................................................................................. 382 12.73 .......................... 501.82 * National Compensation Survey: Occupational wages in the United States May 2018, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Available at: https://www.bls.gov/oes/current/oes290000.htm. a Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000. 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’s 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 AHRQ’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–12606 Filed 6–13–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–1876] Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.’’ The draft guidance document provides FDA’s recommendations on the testing jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:04 Jun 13, 2019 Jkt 247001 for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations. Submit either electronic or written comments on the draft guidance by August 13, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: You may submit comments on any guidance at any time as follows: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–1876 for ‘‘Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27779-27781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12606]


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

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) approve the proposed information collection 
project ``Systematic Review Data Repository.'' In accordance with the 
Paperwork Reduction Act, AHRQ invites the public to comment on this 
proposed information collection.

DATES: Comments on this notice must be received on or before 60 days 
after date of publication.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

[[Page 27780]]


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

SUPPLEMENTARY INFORMATION:

Proposed Project

Systematic Review Data Repository (SRDR)

    In 1997, AHRQ launched an initiative to promote evidence-based 
practice in everyday care through establishment of the Evidence-based 
Practice Center (EPC) Program. Since then, the EPCs have been reviewing 
all relevant scientific literature on a wide spectrum of clinical and 
health services topics to produce various types of evidence reports. A 
majority of these evidence reports are systematic reviews (SRs), which 
are used as evidence bases for clinical practice guidelines, research 
agendas, healthcare coverage, and other health related policies. 
Performing SRs is costly in time, labor, and money. Moreover, there is 
an increasing expectation of quicker turnaround in producing SRs to 
accommodate the fast moving pace of innovations and new scientific 
discoveries in healthcare. Some SRs overlap or are replicated; 
independent teams of SR producers often extract data from the same 
studies, resulting in replication of work. Current methodology makes it 
difficult to harness and reuse previous work when updating SRs.
    In an effort to reduce the economic burden of conducting SRs, the 
EPC Program undertook development of a collaborative, Web-based 
repository of systematic review data called the Systematic Review Data 
Repository (SRDR). This resource serves as both an archive and data 
extraction tool, shared among organizations and individuals producing 
SRs worldwide, enabling the creation of a central database of SR data. 
This database is collaboratively vetted, freely accessible, and 
integrates seamlessly with reviewers' existing workflows, with the 
ultimate goal of facilitating the efficient generation and update of 
evidence reviews, and thus speeding and improving policy-making with 
regards to health care. Currently, there are two versions of the 
database: (1) The original version called ``SRDR''; and (2) an upgraded 
version with increased functionality. Further upgrade of the database 
is planned for the next year (to be called ``SRDR 2.0''). The SRDR 
project encompasses the various iterations of the database.
    The SRDR project aims to achieve the following goals:
    (1) Create online easy-to-use Web-based tools for conducting 
systematic reviews to facilitate extraction of data from primary 
studies;
    (2) Develop an open-access searchable archive of key questions 
addressed in systematic reviews;
    (3) Maintain a public repository of primary study data including 
provision of technical support for repository users; and
    (4) Develop a process for making summary data from systematic 
reviews digitally shareable to end-users.
    This study is being conducted by AHRQ through its contractor, Brown 
University, 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 healthcare services, including 
database development. 42 U.S.C 299a(a)(1) and (8).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Collect registration data and information on SRs from SR 
producers who will populate the SRDR system.
    SRDR uses a three-tiered categorization of users and collection of 
registration data that depends on the type of user: (1) 
``Contributors'' are SR producers who use SRDR as a tool to support 
production of the SR and share scientific data from their SRs. 
Registration data will be collected from these users; (2) 
``Commentators'' provide comments (i.e. opinions) on publicly available 
scientific data in SRDR. Registration data will be collected from these 
users; (3) ``General public'' users only view scientific data publicly 
available in SRDR. No data will be collected from these type of users.
    All Contributors and Commentators will undergo a simple self-
registration process by providing a username, password, email address, 
and institution. Collection of registration data from Contributors and 
Commentators is required due to the use of SRDR both as a database and 
as a tool for assisting in the production of a SR, including providing 
comments in the various sections of a particular project on SRDR. In 
addition, provision of an email address and institution information 
allows the administrators of SRDR to confirm that requests are being 
made by actual people and not potentially malicious software code such 
as bots and other cybersecurity threats.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the SRDR. In 2017, 176 users 
registered as Commentators and 206 users registered as Contributors. 
Registration will take approximately 2 minutes per user. We thus 
calculate the total burden hours required for registration for all 
users annually is 12.73 hours.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
                  Form name                      Number of      responses per      Hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Registration of users as Commentators or                  382                1             2/60            12.73
 Contributors...............................
                                             -------------------------------------------------------------------
    Total...................................              382  ...............  ...............            12.73
----------------------------------------------------------------------------------------------------------------

    Exhibit 2 shows the estimated cost burden associated with the 
respondents' time to participate in the SRDR. The total cost burden to 
respondents is estimated at an average of $501.82 annually.

[[Page 27781]]



                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                 Number of       Total burden    Average hourly     Total cost
                  Form name                     respondents         hours         wage rate *         burden
----------------------------------------------------------------------------------------------------------------
Registration of users as Commentators or                  382            12.73       \a\ $39.42          $501.82
 Contributors...............................
                                             -------------------------------------------------------------------
    Total...................................              382            12.73  ...............           501.82
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2018, ``U.S. Department of Labor,
  Bureau of Labor Statistics.'' Available at: https://www.bls.gov/oes/current/oes290000.htm.
\a\ Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000.

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's 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 AHRQ's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-12606 Filed 6-13-19; 8:45 am]
 BILLING CODE 4160-90-P