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)
Food and Drug Administration
Federal Register Volume 83, Issue 118 (June 19, 2018)
| Page Range | 28430-28431 | |
| FR Document | 2018-13098 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, [email protected]. 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
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![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
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Document Created: 2018-07-02 11:21:40
Document Modified: 2018-07-02 11:21:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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, [email protected] | |
| FR Citation | 83 FR 28430 |
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