81 FR 52878 - 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 81, Issue 154 (August 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 154 (August 10, 2016)
| Page Range | 52878-52879 | |
| FR Document | 2016-19021 |
[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)] [Notices] [Pages 52878-52879] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19021] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2014-N-1721; FDA-2012-N-0248; FDA-2011-N-0449; FDA- 2012-N-0748; FDA-2012-N-0961; FDA-2012-N-0921; FDA-2014-N-0189; FDA- 2004-N-0258] 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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 http://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. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Investigational New Drug Regulations.... 0910-0014 2/28/2019 [[Page 52879]] Guidance for Industry on Formal Dispute 0910-0430 2/28/2019 Resolutions; Appeals Above the Division Level.................................. SPF Labeling and Testing Requirements 0910-0717 2/28/2019 for OTC Sunscreen Products............. Generic Drug User Fee Cover Sheet--Form 0910-0727 2/28/2019 FDA 3794............................... Environmental Impact Considerations..... 0910-0322 4/30/2019 FDA Adverse Event Reports; Electronic 0910-0645 5/31/2019 Submissions............................ Importer's Entry Notice................. 0910-0046 6/30/2019 Exports: Notification and Recordkeeping 0910-0482 6/30/2019 Requirements........................... Focused Mitigation Strategies to Protect 0910-0812 6/30/2019 Food Against Intentional Adulteration.. ------------------------------------------------------------------------ Dated: August 5, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-19021 Filed 8-9-16; 8:45 am] BILLING CODE 4164-01-P
![52878 Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices
SUPPLEMENTARY INFORMATION: Under the provided in 81 FR 29268 (May 11, Number of Respondents: 575; Total
Paperwork Reduction Act of 1995 (PRA) 2016). Form Number: CMS–10463 (OMB Annual Responses: 575; Total Annual
(44 U.S.C. 3501–3520), federal agencies control number: 0938–1215); Frequency: Hours: 13,200. (For policy questions
must obtain approval from the Office of Annually; Quarterly; Monthly; Weekly; regarding this collection contact Pat
Management and Budget (OMB) for each and Quarterly; Affected Public: Private Meisol at 410–786–1917.)
collection of information they conduct sector; Number of Respondents: 102; Dated: August 5, 2016.
or sponsor. The term ‘‘collection of Total Annual Responses: 102; 408;
William N. Parham, III,
information’’ is defined in 44 U.S.C. 1,224; 5,304; Total Annual Hours:
Director, Paperwork Reduction Staff, Office
3502(3) and 5 CFR 1320.3(c) and 24,729. (For policy questions regarding
of Strategic Operations and Regulatory
includes agency requests or this collection, contact Gian Johnson at Affairs.
requirements that members of the public 301–492–4323.)
[FR Doc. 2016–18986 Filed 8–9–16; 8:45 am]
submit reports, keep records, or provide 2. Type of Information Collection
BILLING CODE 4120–01–P
information to a third party. Section Request: Extension of a currently
3506(c)(2)(A) of the PRA (44 U.S.C. approved collection; Title of
3506(c)(2)(A)) requires federal agencies Information Collection: Issuer Reporting
Requirements for Selecting a Cost- DEPARTMENT OF HEALTH AND
to publish a 30-day notice in the HUMAN SERVICES
Federal Register concerning each Sharing Reductions Reconciliation
proposed collection of information, Methodology; Use: Sections 1402 and Food and Drug Administration
including each proposed extension or 1412 of the Affordable Care Act provide
reinstatement of an existing collection for reductions in cost sharing on [Docket Nos. FDA–2014–N–1721; FDA–
of information, before submitting the essential health benefits for low- and 2012–N–0248; FDA–2011–N–0449; FDA–
collection to OMB for approval. To moderate-income enrollees in silver 2012–N–0748; FDA–2012–N–0961; FDA–
comply with this requirement, CMS is level qualified health plans (QHP) on 2012–N–0921; FDA–2014–N–0189; FDA–
individual market Exchanges. It also 2004–N–0258]
publishing this notice that summarizes
the following proposed collection(s) of provides for reductions in cost sharing
for Indians enrolled in QHPs at any Agency Information Collection
information for public comment: Activities; Announcement of Office of
metal level. These cost-sharing
1. Type of Information Collection reductions will help eligible individuals Management and Budget Approvals
Request: Revision of a currently and families afford the out-of-pocket
approved collection; Title of AGENCY: Food and Drug Administration,
spending associated with health care HHS.
Information Collection: Cooperative services provided through Exchange-
Agreement to Support Navigators in ACTION: Notice.
based QHP coverage.
Federally-facilitated and State The law directs QHP issuers to notify
Partnership Exchanges; Use: Section SUMMARY: The Food and Drug
the Secretary of the Department of Administration (FDA) is publishing a
1311(i) of the Affordable Care Act Health and Human Services (HHS) of
requires Exchanges (Marketplaces) to list of information collections that have
cost-sharing reductions made under the been approved by the Office of
establish a Navigator grant program as statute for qualified individuals, and
part of its function to provide Management and Budget (OMB) under
directs the Secretary to make periodic the Paperwork Reduction Act of 1995.
consumers with assistance when they and timely payments to the QHP issuer
need it. Navigators will assist FOR FURTHER INFORMATION CONTACT: FDA
equal to the value of those reductions.
consumers by providing education Further, the law permits advance PRA Staff, Office of Operations, Food
about and facilitating selection of payment of the cost-sharing reduction and Drug Administration, Three White
qualified health plans (QHPs) within amounts to QHP issuers based upon Flint North, 10A63, 11601 Landsdown
Marketplaces, as well as other required amounts specified by the Secretary. St., North Bethesda, MD 20852,
duties. Section 1311(i) requires that a Under established HHS regulations, PRAStaff@fda.hhs.gov.
Marketplace operating as of January 1, QHP issuers will receive advance SUPPLEMENTARY INFORMATION: The
2014, must establish a Navigator payments of the cost-sharing reductions following is a list of FDA information
Program under which it awards grants throughout the year. Each issuer will collections recently approved by OMB
to eligible individuals or entities who then be subject to one of two under section 3507 of the Paperwork
satisfy the requirements to be Exchange reconciliation processes after the year to Reduction Act of 1995 (44 U.S.C. 3507).
Navigators. For Federally-facilitated ensure that HHS reimbursed each issuer The OMB control number and
Marketplaces (FFMs) and State the correct cost-sharing portion of expiration date of OMB approval for
Partnership Marketplaces (SPMs), CMS advance payments. This information each information collection are shown
will be awarding these grants. Navigator collection request establishes the data in table 1. Copies of the supporting
awardees must provide weekly, collection requirements for a QHP issuer statements for the information
monthly, quarterly, and annual progress to report to HHS which reconciliation collections are available on the Internet
reports to CMS on the activities reporting option the issuer will be at http://www.reginfo.gov/public/do/
performed during the grant period and subject to for a given benefit year. Form PRAMain. An Agency may not conduct
any sub-awardees receiving funds. CMS Number: CMS–10469 (OMB control or sponsor, and a person is not required
has modified the data collection number: 0938–1214); Frequency: to respond to, a collection of
requirements for the weekly, monthly, Annually; Affected Public: Private information unless it displays a
quarterly, and annual reports that were sector (Businesses or other for-profits); currently valid OMB control number.
mstockstill on DSK3G9T082PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Investigational New Drug Regulations .................................................................................................................... 0910–0014 2/28/2019
VerDate Sep<11>2014 17:34 Aug 09, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1](https://thefederalregister.org/doc/81_FR_53032/page/1.svg)
![Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices 52879
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control Date approval
Title of collection No. expires
Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level ................................... 0910–0430 2/28/2019
SPF Labeling and Testing Requirements for OTC Sunscreen Products ............................................................... 0910–0717 2/28/2019
Generic Drug User Fee Cover Sheet—Form FDA 3794 ........................................................................................ 0910–0727 2/28/2019
Environmental Impact Considerations ..................................................................................................................... 0910–0322 4/30/2019
FDA Adverse Event Reports; Electronic Submissions ............................................................................................ 0910–0645 5/31/2019
Importer’s Entry Notice ............................................................................................................................................ 0910–0046 6/30/2019
Exports: Notification and Recordkeeping Requirements ......................................................................................... 0910–0482 6/30/2019
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration .................................................... 0910–0812 6/30/2019
Dated: August 5, 2016. Silver Spring, MD 20993–0002, 301– orally or in writing, on issues pending
Jeremy Sharp, 796–9001, FAX: 301–847–8533, before the committee. Written
Deputy Commissioner for Policy, Planning, AADPAC@fda.hhs.gov, or FDA submissions may be made to the contact
Legislation, and Analysis. Advisory Committee Information Line, person on or before September 21, 2016.
[FR Doc. 2016–19021 Filed 8–9–16; 8:45 am] 1–800–741–8138 (301–443–0572 in the Oral presentations from the public will
BILLING CODE 4164–01–P Washington, DC area). A notice in the be scheduled between approximately 1
Federal Register about last minute p.m. and 2 p.m. Those individuals
modifications that impact a previously interested in making formal oral
DEPARTMENT OF HEALTH AND announced advisory committee meeting presentations should notify the contact
HUMAN SERVICES cannot always be published quickly person and submit a brief statement of
enough to provide timely notice. the general nature of the evidence or
Food and Drug Administration Therefore, you should always check the arguments they wish to present, the
[Docket No. FDA–2016–N–0001] Agency’s Web site at http:// names and addresses of proposed
www.fda.gov/AdvisoryCommittees/ participants, and an indication of the
Anesthetic and Analgesic Drug default.htm and scroll down to the approximate time requested to make
Products Advisory Committee and the appropriate advisory committee meeting their presentation on or before
Drug Safety and Risk Management link, or call the advisory committee September 13, 2016. Time allotted for
Advisory Committee; Notice of Meeting information line to learn about possible each presentation may be limited. If the
modifications before coming to the number of registrants requesting to
AGENCY: Food and Drug Administration, meeting.
HHS. speak is greater than can be reasonably
SUPPLEMENTARY INFORMATION: accommodated during the scheduled
ACTION: Notice.
Agenda: The committees will be open public hearing session, FDA may
SUMMARY: The Food and Drug asked to discuss naloxone products conduct a lottery to determine the
Administration (FDA) announces a intended for use in the community, speakers for the scheduled open public
forthcoming public advisory committee specifically the most appropriate dose hearing session. The contact person will
meeting of the Anesthetic and Analgesic or doses of naloxone to reverse the notify interested persons regarding their
Drug Products Advisory Committee and effects of life-threatening opioid request to speak by September 14, 2016.
the Drug Safety and Risk Management overdose in all ages, and the role of
Persons attending FDA’s advisory
Advisory Committee. The general having multiple doses available in this
committee meetings are advised that the
function of the committees is to provide setting. The committees will also be
Agency is not responsible for providing
advice and recommendations to the asked to discuss the criteria prescribers
access to electrical outlets.
Agency on FDA’s regulatory issues. The will use to select the most appropriate
meeting will be open to the public. dose in advance of an opioid overdose FDA welcomes the attendance of the
event and the labeling to inform this public at its advisory committee
DATES: The meeting will be held on
decision, if multiple doses are available. meetings and will make every effort to
October 5, 2016, from 8 a.m. to 5 p.m.
FDA intends to make background accommodate persons with disabilities.
ADDRESSES: FDA White Oak Campus,
material available to the public no later If you require accommodations due to a
10903 New Hampshire Ave., Bldg. 31 than 2 business days before the meeting. disability, please contact Jennifer
Conference Center, the Great Room (Rm. If FDA is unable to post the background Shepherd at least 7 days in advance of
1503), Silver Spring, MD 20993–0002. material on its Web site prior to the the meeting.
Answers to commonly asked questions meeting, the background material will
including information regarding special FDA is committed to the orderly
be made publicly available at the
accommodations due to a disability, conduct of its advisory committee
location of the advisory committee
visitor parking, and transportation may meetings. Please visit our Web site at
meeting, and the background material
be accessed at: http://www.fda.gov/ http://www.fda.gov/
will be posted on FDA’s Web site after
AdvisoryCommittees/ AdvisoryCommittees/
the meeting. Background material is
mstockstill on DSK3G9T082PROD with NOTICES
AboutAdvisoryCommittees/ AboutAdvisoryCommittees/
available at http://www.fda.gov/
ucm408555.htm. AdvisoryCommittees/Calendar/ ucm111462.htm for procedures on
FOR FURTHER INFORMATION CONTACT: default.htm. Scroll down to the public conduct during advisory
Jennifer Shepherd, Center for Drug appropriate advisory committee meeting committee meetings.
Evaluation and Research, Food and link. Notice of this meeting is given under
Drug Administration, 10903 New Procedure: Interested persons may the Federal Advisory Committee Act (5
Hampshire Ave., Bldg. 31, Rm. 2417, present data, information, or views, U.S.C. app. 2).
VerDate Sep<11>2014 18:44 Aug 09, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1](https://thefederalregister.org/doc/81_FR_53032/page/2.svg)
Document Created: 2016-08-10 01:59:40
Document Modified: 2016-08-10 01:59:40
| 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 | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 52878 |
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