83_FR_28548 83 FR 28430 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

83 FR 28430 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 118 (June 19, 2018)

Page Range28430-28431
FR Document2018-13098

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 118 (Tuesday, June 19, 2018) 
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Notices]
[Pages 28430-28431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0545; FDA-2013-N-0878; FDA-2014-N-0998; FDA-
2014-N-1076; FDA-2017-N-6162; FDA-2011-N-0510; FDA-2014-N-1414; FDA-
2008-D-0610; FDA-2010-D-0073; FDA-2013-N-0080; FDA-2017-N-6397; FDA-
2014-D-0313; FDA-2014-N-1030; and FDA-2014-D-1837]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

[[Page 28431]]



        Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Infant Formula Requirements.............       0910-0256       5/31/2021
Premarket Notification for a New Dietary       0910-0330       5/31/2021
 Ingredient.............................
Regulations for In Vivo                        0910-0409       5/31/2021
 Radiopharmaceuticals Used for Diagnosis
 and Monitoring.........................
Guidance for Industry: Formal Dispute          0910-0563       5/31/2021
 Resolution; Scientific and Technical
 Issues Related to Pharmaceutical
 Current Good Manufacturing Practice....
Requests for Inspection by an Accredited       0910-0569       5/31/2021
 Person Under the Inspection for
 Accredited Persons Program.............
Substances Prohibited from Use in Animal       0910-0627       5/31/2021
 Food or Feed...........................
Class II Special Controls Guidance             0910-0633       5/31/2021
 Document: Labeling for Natural Rubber
 Latex Condoms Classified Under 21 CFR
 884.5300...............................
Guidance for Industry: Postmarketing           0910-0701       5/31/2021
 Adverse Event Reporting for Medical
 Products and Dietary Supplements During
 an Influenza Pandemic..................
Guidance on Consultation Procedures:           0910-0704       5/31/2021
 Foods Derived From New Plant Varieties.
Human Subject Protection; Acceptance of        0910-0741       5/31/2021
 Data From Clinical Investigations for
 Medical Devices........................
Food Labeling; Calorie Labeling of             0910-0782       5/31/2021
 Articles of Food in Vending Machines
 and Nutrition Labeling of Standard Menu
 Items in Restaurants and Similar Retail
 Food Establishments....................
Guidance for Industry, Researchers,            0910-0787       5/31/2021
 Patient Groups, and Food and Drug
 Administration Staff on Meetings with
 the Office of Orphan Products
 Development............................
Food Allergen Labeling and Reporting....       0910-0792       5/31/2021
Transfer of a Premarket Notification           0910-0852       5/31/2021
 Clearance..............................
------------------------------------------------------------------------


    Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13098 Filed 6-18-18; 8:45 am]
 BILLING CODE 4164-01-P

28430 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices to the State Medicaid Agency and the Dated: June 14, 2018. Title: Evaluation of Services provided Protection and Advocacy Organization. William N. Parham, III, to Repatriates. They are also required to provide Director, Paperwork Reduction Staff, Office OMB No.: residents the restraint and seclusion of Strategic Operations and Regulatory policy in writing, and to document in Affairs. Description: The Department of the residents’ records all activities [FR Doc. 2018–13149 Filed 6–18–18; 8:45 am] Health and Human Services, involving the use of restraint and BILLING CODE 4120–01–P Administration for Children and seclusion. Form Number: CMS–R–306 Families, Office of Refugee Resettlement (OMB Control Number 0938–0833); (ORR) is conducting an after event DEPARTMENT OF HEALTH AND analysis of the activation of the Frequency: Occasionally; Affected HUMAN SERVICES Emergency Repatriation Plan and Public: Private sector (Business or other for-profits); Number of Respondents: overall response during recent Administration for Children and 390; Total Annual Responses: emergency repatriation. In an effort to Families 1,466,823; Total Annual Hours: 449,609. strengthen our operations, learn from (For policy questions regarding this Proposed Information Collection our experience, and ensure quality collection contact Kirsten Jensen at 410– Activity; Comment Request services in future similar efforts. 786–8146). (Evaluation of services provided). Proposed Projects: Emergency Repatriation (After Analysis Respondents: Repatriates Questionnaire). (International Social Services ISS–USA). ANNUAL BURDEN ESTIMATES Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response 1 (Repatriates Questionnaire) Assessment ..................................................... 100–5000 1 1 1 1 (State Questionnaire Assessment) ............................................................... 100–500 1 1 1 Estimated Total Annual Burden respondents, including through the use SUMMARY: The Food and Drug Hours: 2 Hours. of automated collection techniques or Administration (FDA) is publishing a In compliance with the requirements other forms of information technology. list of information collections that have of the Paperwork Reduction Act of 1995 Consideration will be given to been approved by the Office of (Pub. L. 104–13, 44 U.S.C. Chap 35), the comments and suggestions submitted Management and Budget (OMB) under Administration for Children and within 60 days of this publication. the Paperwork Reduction Act of 1995. Families is soliciting public comment Robert A. Sargis, on the specific aspects of the FOR FURTHER INFORMATION CONTACT: Ila Reports Clearance Officer. S. Mizrachi, Office of Operations, Food information collection described above. [FR Doc. 2018–13060 Filed 6–18–18; 8:45 am] and Drug Administration, Three White Copies of the proposed collection of information can be obtained and BILLING CODE 4184–01–P Flint North, 10A–12M, 11601 comments may be forwarded by writing Landsdown St., North Bethesda, MD to the Administration for Children and 20852, 301–796–7726, PRAStaff@ DEPARTMENT OF HEALTH AND Families, Office of Planning, Research fda.hhs.gov. HUMAN SERVICES and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF SUPPLEMENTARY INFORMATION: The Food and Drug Administration Reports Clearance Officer. Email following is a list of FDA information address: infocollection@acf.hhs.gov. All [Docket Nos. FDA–2013–N–0545; FDA– collections recently approved by OMB requests should be identified by the title 2013–N–0878; FDA–2014–N–0998; FDA– under section 3507 of the Paperwork of the information collection. 2014–N–1076; FDA–2017–N–6162; FDA– Reduction Act of 1995 (44 U.S.C. 3507). 2011–N–0510; FDA–2014–N–1414; FDA– The OMB control number and The Department specifically requests 2008–D–0610; FDA–2010–D–0073; FDA– comments on: (a) Whether the proposed 2013–N–0080; FDA–2017–N–6397; FDA– expiration date of OMB approval for collection of information is necessary 2014–D–0313; FDA–2014–N–1030; and each information collection are shown for the proper performance of the FDA–2014–D–1837] in table 1. Copies of the supporting functions of the agency, including statements for the information whether the information shall have Agency Information Collection collections are available on the internet practical utility; (b) the accuracy of the Activities; Announcement of Office of at https://www.reginfo.gov/public/do/ agency’s estimate of the burden of the Management and Budget Approvals PRAMain. An Agency may not conduct proposed collection of information; (c) AGENCY: Food and Drug Administration, or sponsor, and a person is not required the quality, utility, and clarity of the to respond to, a collection of daltland on DSKBBV9HB2PROD with NOTICES HHS. information to be collected; and (d) information unless it displays a ways to minimize the burden of the ACTION: Notice. currently valid OMB control number. collection of information on VerDate Sep<11>2014 17:55 Jun 18, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices 28431 TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB Date OMB Title of collection approval control No. expires Infant Formula Requirements .................................................................................................................................. 0910–0256 5/31/2021 Premarket Notification for a New Dietary Ingredient ............................................................................................... 0910–0330 5/31/2021 Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring .............................................. 0910–0409 5/31/2021 Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice ................................................................................................................. 0910–0563 5/31/2021 Requests for Inspection by an Accredited Person Under the Inspection for Accredited Persons Program .......... 0910–0569 5/31/2021 Substances Prohibited from Use in Animal Food or Feed ..................................................................................... 0910–0627 5/31/2021 Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 ................................................................................................................................................. 0910–0633 5/31/2021 Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic ............................................................................................................................. 0910–0701 5/31/2021 Guidance on Consultation Procedures: Foods Derived From New Plant Varieties ............................................... 0910–0704 5/31/2021 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ...................... 0910–0741 5/31/2021 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments ................................................................. 0910–0782 5/31/2021 Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development ....................................................................................................... 0910–0787 5/31/2021 Food Allergen Labeling and Reporting .................................................................................................................... 0910–0792 5/31/2021 Transfer of a Premarket Notification Clearance ...................................................................................................... 0910–0852 5/31/2021 Dated: June 13, 2018. Amount of Non-Competitive Award: provide jurisdictions with strategies, Leslie Kux, $300,000 in FY 2018. tools, and resources to effectively Associate Commissioner for Policy. Period of Funding: July 1, 2018, allocate annual available resources to [FR Doc. 2018–13098 Filed 6–18–18; 8:45 am] through June 30, 2019. prioritize HIV unmet needs. The TA CFDA Number: No. 93.145. activities will be directed at addressing BILLING CODE 4164–01–P Authority: Sections 2606 and 2654(b) more efficient and proactive methods in of the Public Health Service Act, as the Priority Setting and Resource DEPARTMENT OF HEALTH AND amended by the Ryan White HIV/AIDS Allocation (PSRA) process to increase HUMAN SERVICES Treatment Extension Act of 2009 (Pub. the ability of health care providers and L. 111–87). systems to ensure people living with Health Resources and Services Justification: In 2016, JSI was awarded HIV are linked to care, remain engaged Administration a 3-year cooperative agreement under in care, and achieve HIV viral HRSA–16–082 RWHAP Integrated HIV suppression. Ryan White HIV/AIDS Program Parts A Planning Implementation (CFDA 93.145), authorized by Sections 2606 Dated: June 12, 2018. and B Integrated HIV Planning and 2654(b) of the Public Health Service George Sigounas, Implementation Cooperative Agreement to John Snow, Inc. (JSI), Act, as amended by the Ryan White Administrator. U69HA30144 HIV/AIDS Treatment Extension Act of [FR Doc. 2018–13121 Filed 6–18–18; 8:45 am] 2009 (Pub. L. 111–87). The cooperative BILLING CODE 4165–15–P AGENCY: Health Resources and Services agreement was established to provide Administration (HRSA), Department of technical assistance to RWHAP Parts A Health and Human Services. and B recipients and their planning DEPARTMENT OF HEALTH AND ACTION: Notice of non-competitive FY bodies regarding: (1) The integration of HUMAN SERVICES 2018 supplemental award. HIV planning across prevention, care, and treatment service delivery systems; National Institutes of Health SUMMARY: This noncompetitive and (2) the development, supplement award to JSI will support National Institute of Allergy and implementation, monitoring, and and strengthen current Ryan White HIV/ Infectious Diseases; Notice of Closed evaluation of Integrated HIV Prevention AIDS Program (RWHAP) Part A and Part Meetings and Care Plans. RWHAP Parts A and B B priority setting and resource recipients and planning bodies use Pursuant to section 10(d) of the allocation processes to ensure people Integrated Plans to better inform and Federal Advisory Committee Act, as living with HIV are linked to care, coordinate HIV prevention and care amended, notice is hereby given of the remain engaged in care, and achieve program planning, resource allocation, following meetings. viral suppression. and continuous quality improvement The meetings will be closed to the FOR FURTHER INFORMATION CONTACT: Dr. efforts to meet the HIV service delivery public in accordance with the Rene Sterling, Acting Director, Division needs within their jurisdictions. provisions set forth in sections of State HIV/AIDS Programs, HIV/AIDS The proposed supplemental funding 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., daltland on DSKBBV9HB2PROD with NOTICES Bureau, HRSA; 5600 Fishers Lane, will provide RWHAP Parts A and B as amended. The grant applications and Room 09W50, Rockville, MD 20857; recipients with additional technical the discussions could disclose Phone: (301) 443–9017, Email: assistance (TA) specifically focused on confidential trade secrets or commercial rsterling@hrsa.gov. resource allocation planning and property such as patentable material, SUPPLEMENTARY INFORMATION: implementation. These additional TA and personal information concerning Intended Recipient of the Award: JSI activities will build upon data elements individuals associated with the grant (U69HA30144). identified in the Integrated Plan and applications, the disclosure of which VerDate Sep<11>2014 17:55 Jun 18, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1


Document Created: 2018-07-02 11:21:40
Document Modified: 2018-07-02 11:21:40
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.
ContactIla S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation83 FR 28430 
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