81_FR_40824 81 FR 40704 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Nonproprietary Naming of Biological Products; Withdrawal

81 FR 40704 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Nonproprietary Naming of Biological Products; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 120 (June 22, 2016)

Page Range40704-40704
FR Document2016-14722

This document withdraws a Food and Drug Administration (FDA) notice that published in the Federal Register of June 2, 2016 (81 FR 35367).

Federal Register, Volume 81 Issue 120 (Wednesday, June 22, 2016)
[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Page 40704]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Nonproprietary Naming of Biological Products; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of notice.

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SUMMARY: This document withdraws a Food and Drug Administration (FDA) 
notice that published in the Federal Register of June 2, 2016 (81 FR 
35367).

DATES: This notice is withdrawn on June 22, 2016.

FOR FURTHER INFORMATION CONTACT: Howard Muller, Center for Drug 
Evaluation and Research (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 
6234, Silver Spring, MD 20993-0002, 301-796-3474.

SUPPLEMENTARY INFORMATION: FDA published a notice in the Federal 
Register of June 2, 2016, informing interested parties that the 
proposed collection of information entitled ``Guidance for Industry on 
Nonproprietary Naming of Biological Products'' had been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 and inviting the public to 
submit comments on the proposed collection to OMB. FDA is withdrawing 
the proposed collection of information that published on June 2, 2016, 
at this time.

    Dated: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14722 Filed 6-21-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                  40704                        Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices

                                                  investigations per year. Each                           is 2,084 hours. There will be no cost to
                                                  investigation will involve on average                   the respondents other than their time.
                                                  200 respondents. The total time burden

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

                                                  Adult at least 18 years old using a private            Screening Form ..............................................            2,500                1           6/60
                                                    well for tap water.
                                                                                                         Questionnaire .................................................          2,000                1          35/60
                                                                                                         Urine Specimen and Tap Water Sample Col-                                 2,000                1          20/60
                                                                                                           lection.



                                                  Leroy A. Richardson,                                    OMB. FDA is withdrawing the proposed                              or call the HRSA Information Collection
                                                  Chief, Information Collection Review Office,            collection of information that published                          Clearance Officer at (301) 443–1984.
                                                  Office of Scientific Integrity, Office of the           on June 2, 2016, at this time.
                                                  Associate Director for Science, Office of the                                                                             SUPPLEMENTARY INFORMATION:    When
                                                                                                            Dated: June 16, 2016.                                           submitting comments or requesting
                                                  Director, Centers for Disease Control and
                                                  Prevention.                                             Leslie Kux,                                                       information, please include the
                                                  [FR Doc. 2016–14724 Filed 6–21–16; 8:45 am]             Associate Commissioner for Policy.                                information request collection title for
                                                  BILLING CODE 4163–18–P                                  [FR Doc. 2016–14722 Filed 6–21–16; 8:45 am]                       reference.
                                                                                                          BILLING CODE 4164–01–P                                            Information Collection Request Title:
                                                                                                                                                                            Data Collection Tool for State Offices of
                                                  DEPARTMENT OF HEALTH AND                                                                                                  Rural Health Grant Program
                                                  HUMAN SERVICES                                          DEPARTMENT OF HEALTH AND
                                                                                                          HUMAN SERVICES                                                    OMB No. 0915–0322—Extension
                                                  Food and Drug Administration
                                                                                                          Health Resources and Services                                        Abstract: The mission of the Federal
                                                  [Docket No. FDA–2013–D–1543]                                                                                              Office of Rural Health Policy (FORHP)
                                                                                                          Administration
                                                                                                                                                                            is to sustain and improve access to
                                                  Agency Information Collection
                                                                                                          Agency Information Collection                                     quality care services for rural
                                                  Activities; Submission for Office of
                                                                                                          Activities: Proposed Collection: Public                           communities. In its authorizing
                                                  Management and Budget Review;
                                                                                                          Comment Request                                                   language (section 711 of the Social
                                                  Comment Request; Guidance for
                                                                                                                                                                            Security Act [42 U.S.C. 912]), Congress
                                                  Industry on Nonproprietary Naming of                    AGENCY: Health Resources and Services                             charged FORHP with administering
                                                  Biological Products; Withdrawal                         Administration, HHS.                                              grants, cooperative agreements, and
                                                  AGENCY:    Food and Drug Administration,                ACTION: Notice.                                                   contracts to provide technical assistance
                                                  HHS.                                                                                                                      and other activities as necessary to
                                                                                                          SUMMARY:   In compliance with the                                 support activities related to improving
                                                  ACTION:   Withdrawal of notice.                         requirement for opportunity for public                            health care in rural areas. In accordance
                                                  SUMMARY:   This document withdraws a                    comment on proposed data collection                               with the Public Health Service Act,
                                                  Food and Drug Administration (FDA)                      projects (section 3506(c)(2)(A) of the                            section 338J (42 U.S.C. 254r), HRSA
                                                  notice that published in the Federal                    Paperwork Reduction Act of 1995), the                             proposes to continue the State Offices of
                                                  Register of June 2, 2016 (81 FR 35367).                 Health Resources and Services                                     Rural Health (SORH) Grant Program—
                                                  DATES: This notice is withdrawn on June
                                                                                                          Administration (HRSA) announces                                   Funding Opportunity Announcement
                                                  22, 2016.                                               plans to submit an Information                                    (FOA) and Forms for the Application.
                                                                                                          Collection Request (ICR), described                               The FOA is used by 50 states in
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                          below, to the Office of Management and                            preparing applications for grants under
                                                  Howard Muller, Center for Drug                          Budget (OMB). Prior to submitting the
                                                  Evaluation and Research (CDER), 10903                                                                                     the SORH Grant Program of the Public
                                                                                                          ICR to OMB, HRSA seeks comments                                   Health Service Act, and in preparing the
                                                  New Hampshire Ave., Bldg. 51, Rm.                       from the public regarding the burden
                                                  6234, Silver Spring, MD 20993–0002,                                                                                       required report.
                                                                                                          estimate, below, or any other aspect of
                                                  301–796–3474.                                           the ICR.                                                             Need and Proposed Use of the
                                                  SUPPLEMENTARY INFORMATION: FDA                                                                                            Information: FORHP seeks to continue
                                                                                                          DATES: Comments on this ICR should be
                                                  published a notice in the Federal                                                                                         gathering information from grantees on
                                                                                                          received no later than August 22, 2016.
                                                  Register of June 2, 2016, informing                                                                                       their efforts to provide technical
                                                  interested parties that the proposed                    ADDRESSES: Submit your comments to                                assistance to clients within their states.
                                                  collection of information entitled                      paperwork@hrsa.gov or mail the HRSA                               SORH grantees submit a Technical
                                                  ‘‘Guidance for Industry on                              Information Collection Clearance                                  Assistance Report that includes: (1) The
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Nonproprietary Naming of Biological                     Officer, Room 14N–39, 5600 Fishers                                total number of technical assistance
                                                  Products’’ had been submitted to the                    Lane, Rockville, MD 20857.                                        encounters provided directly by the
                                                  Office of Management and Budget                         FOR FURTHER INFORMATION CONTACT: To                               grantee, and (2) the total number of
                                                  (OMB) for review and clearance under                    request more information on the                                   unduplicated clients that received direct
                                                  the Paperwork Reduction Act of 1995                     proposed project or to obtain a copy of                           technical assistance from the grantee.
                                                  and inviting the public to submit                       the data collection plans and draft                               The Technical Assistance Report is
                                                  comments on the proposed collection to                  instruments, email paperwork@hrsa.gov                             submitted via the HRSA Electronic


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Document Created: 2016-06-22 01:06:05
Document Modified: 2016-06-22 01:06:05
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
ActionWithdrawal of notice.
DatesThis notice is withdrawn on June 22, 2016.
ContactHoward Muller, Center for Drug Evaluation and Research (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 6234, Silver Spring, MD 20993-0002, 301-796-3474.
FR Citation81 FR 40704 

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