82 FR 30875 - 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 82, Issue 126 (July 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 126 (July 3, 2017)
| Page Range | 30875-30876 | |
| FR Document | 2017-13890 |
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)] [Notices] [Pages 30875-30876] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13890] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-N-2976; FDA-2016-N-3535; FDA-2013-N-1089; FDA- 2013-N-1619; FDA-2013-N-0719; FDA-2016-N-3586; FDA-2013-N-0796; FDA- 2016-N-0736; FDA-2016-N-3995; FDA-2013-D-0575; FDA-2016-N-0735] 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, 10A63, 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. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Request for Information From U.S. 0910-0320 5/31/2020 Processors That Export to the European Community.............................. Guidance for Industry: Special Protocol 0910-0470 5/31/2020 Assessment............................. Use of Symbols on Labels and in Labeling 0910-0553 5/31/2020 of In Vitro Diagnostic Devices Intended for Professional Use................... Current Good Manufacturing Practice in 0910-0606 5/31/2020 Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements............................ Guidance for Industry: Planning for the 0910-0675 5/31/2020 Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.......................... [[Page 30876]] Focus Groups About Drug Products as Used 0910-0677 5/31/2020 by the Food and Drug Administration.... Testing Communication on Medical Devices 0910-0678 5/31/2020 and Radiation-Emitting Products........ Tracking Network for PETNet, 0910-0680 5/31/2020 LivestockNet, and SampleNet............ Medical Devices: Pediatric Uses of 0910-0748 5/31/2020 Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure...................... Guidance for Industry: Expedited 0910-0765 5/31/2020 Programs for Serious Conditions--Drugs and Biologics.......................... Superimposed Text in Direct-to-Consumer 0910-0831 5/31/2020 Promotion of Prescription Drugs........ ------------------------------------------------------------------------ Dated: June 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13890 Filed 6-30-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices 30875
default.htm and scroll down to the the contact person and submit a brief Dated: June 27, 2017.
appropriate advisory committee meeting statement of the general nature of the Anna K. Abram,
link, or call the advisory committee evidence or arguments they wish to Deputy Commissioner for Policy, Planning,
information line to learn about possible present, the names and addresses of Legislation, and Analysis.
modifications before coming to the proposed participants, and an [FR Doc. 2017–13887 Filed 6–30–17; 8:45 am]
meeting. indication of the approximate time BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION: requested to make their presentation on
Agenda: The committees will discuss or before July 3, 2017. Time allotted for
new drug application (NDA) 209653, for each presentation may be limited. If the DEPARTMENT OF HEALTH AND
oxycodone hydrochloride extended- number of registrants requesting to HUMAN SERVICES
release oral tablets, submitted by speak is greater than can be reasonably
Intellipharmaceutics Corp., with the Food and Drug Administration
accommodated during the scheduled
proposed indication of management of open public hearing session, FDA may [Docket Nos. FDA–2016–N–2976; FDA–
moderate-to-severe pain when a conduct a lottery to determine the 2016–N–3535; FDA–2013–N–1089; FDA–
continuous around-the-clock analgesic speakers for the scheduled open public 2013–N–1619; FDA–2013–N–0719; FDA–
is needed for an extended period of 2016–N–3586; FDA–2013–N–0796; FDA–
hearing session. The contact person will
time. The product has been formulated 2016–N–0736; FDA–2016–N–3995; FDA–
with properties intended to deter abuse, notify interested persons regarding their 2013–D–0575; FDA–2016–N–0735]
and the applicant has submitted data to request to speak by July 5, 2017.
support these abuse-deterrent properties Closed Committee Deliberations: On Agency Information Collection
for this product. The committees will be July 26, 2017, from 8 a.m. to 9:15 a.m., Activities; Announcement of Office of
asked to discuss the overall risk-benefit the meeting will be closed to permit Management and Budget Approvals
profile of the product, and whether the discussion and review of trade secret AGENCY: Food and Drug Administration,
applicant has demonstrated abuse- and/or confidential commercial HHS.
deterrent properties for their product information (5 U.S.C. 552b(c)(4)).
that would support labeling. ACTION: Notice.
During this session, the committees will
FDA intends to make background discuss the drug development program SUMMARY: The Food and Drug
material available to the public no later of an investigational abuse-deterrent Administration (FDA) is publishing a
than 2 business days before the meeting. list of information collections that have
opioid product.
If FDA is unable to post the background been approved by the Office of
material on its Web site prior to the Persons attending FDA’s advisory
committee meetings are advised that the Management and Budget (OMB) under
meeting, the background material will the Paperwork Reduction Act of 1995.
be made publicly available at the Agency is not responsible for providing
location of the advisory committee access to electrical outlets. FOR FURTHER INFORMATION CONTACT: Ila
meeting, and the background material S. Mizrachi, Office of Operations, Food
FDA welcomes the attendance of the and Drug Administration, Three White
will be posted on FDA’s Web site after public at its advisory committee
the meeting. Background material is Flint North, 10A63, 11601 Landsdown
meetings and will make every effort to St., North Bethesda, MD 20852, (301)
available at https://www.fda.gov/ accommodate persons with disabilities.
AdvisoryCommittees/Calendar/ 796–7726, PRAStaff@fda.hhs.gov.
If you require accommodations due to a SUPPLEMENTARY INFORMATION: The
default.htm. Scroll down to the
disability, please contact Stephanie L. following is a list of FDA information
appropriate advisory committee meeting
link. Begansky at least 7 days in advance of collections recently approved by OMB
Procedure: On July 26, 2017, from the meeting. under section 3507 of the Paperwork
9:15 a.m. to 5 p.m., the meeting is open FDA is committed to the orderly Reduction Act of 1995 (44 U.S.C. 3507).
to the public. Interested persons may conduct of its advisory committee The OMB control number and
present data, information, or views, meetings. Please visit our Web site at expiration date of OMB approval for
orally or in writing, on issues pending https://www.fda.gov/ each information collection are shown
before the committees. All electronic AdvisoryCommittees/ in table 1. Copies of the supporting
and written submissions submitted to AboutAdvisoryCommittees/ statements for the information
the docket (see ADDRESSES) on or before ucm111462.htm for procedures on collections are available on the Internet
July 12, 2017, will be provided to the public conduct during advisory at https://www.reginfo.gov/public/do/
committees. Oral presentations from the committee meetings. PRAMain. An Agency may not conduct
public will be scheduled between or sponsor, and a person is not required
approximately 1:30 p.m. and 2:30 p.m. Notice of this meeting is given under to respond to, a collection of
Those individuals interested in making the Federal Advisory Committee Act (5 information unless it displays a
formal oral presentations should notify U.S.C. app. 2). currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
sradovich on DSK3GMQ082PROD with NOTICES
Request for Information From U.S. Processors That Export to the European Community ................................... 0910–0320 5/31/2020
Guidance for Industry: Special Protocol Assessment ............................................................................................. 0910–0470 5/31/2020
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use .......... 0910–0553 5/31/2020
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements ........................................................................................................................................................ 0910–0606 5/31/2020
Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Nec-
essary Drug Products .......................................................................................................................................... 0910–0675 5/31/2020
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![30876 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
Date
OMB
Title of collection approval
control No. expires
Focus Groups About Drug Products as Used by the Food and Drug Administration ............................................ 0910–0677 5/31/2020
Testing Communication on Medical Devices and Radiation-Emitting Products ..................................................... 0910–0678 5/31/2020
Tracking Network for PETNet, LivestockNet, and SampleNet ................................................................................ 0910–0680 5/31/2020
Medical Devices: Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Sub-
populations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure 0910–0748 5/31/2020
Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics .................................. 0910–0765 5/31/2020
Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs ........................................................ 0910–0831 5/31/2020
Dated: June 27, 2017. issues and topics pertaining to or comment should email or fax their
Anna K. Abram, associated with the protection of human comments to SACHRP at SACHRP@
Deputy Commissioner for Policy, Planning, research subjects. hhs.gov at least five business days prior
Legislation, and Analysis. The Subpart A Subcommittee (SAS) to the meeting.
[FR Doc. 2017–13890 Filed 6–30–17; 8:45 am] was established by SACHRP in October Public attendance at the meeting is
BILLING CODE 4164–01–P 2006 and is charged with developing limited to space available. Individuals
recommendations for consideration by who plan to attend and need special
SACHRP regarding the application of assistance, such as sign language
DEPARTMENT OF HEALTH AND subpart A of 45 CFR part 46 in the interpretation or other reasonable
HUMAN SERVICES current research environment. accommodations, should notify one of
The Subcommittee on Harmonization the designated SACHRP points of
Meeting of the Secretary’s Advisory (SOH) was established by SACHRP at its contact at the address/phone number
Committee on Human Research July 2009 meeting and charged with listed above at least one week prior to
Protections identifying and prioritizing areas in the meeting.
which regulations and/or guidelines for Dated: June 27, 2017.
AGENCY: Office of the Secretary, Office
human subjects research adopted by
of the Assistant Secretary for Health, Julia G. Gorey,
various agencies or offices within HHS
Department of Health and Human Executive Director, Secretary’s Advisory
would benefit from harmonization,
Services. Committee on Human Research Protections.
consistency, clarity, simplification and/
ACTION: Notice. or coordination. [FR Doc. 2017–13932 Filed 6–30–17; 8:45 am]
The SACHRP meeting will open to the BILLING CODE 4150–36–P
SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act, public at 8:30 a.m., on Tuesday, July 25,
notice is hereby given that the 2017, followed by opening remarks from
Dr. Jerry Menikoff, Director, Office for DEPARTMENT OF HEALTH AND
Secretary’s Advisory Committee on HUMAN SERVICES
Human Research Protections (SACHRP) Human Research Protections and Dr.
will hold a meeting that will be open to Stephen Rosenfeld, SACHRP Chair. Public Stakeholder Listening Session
the public. Information about SACHRP (https://www.gpo.gov/fdsys/pkg/FR- on Strategies for Improving Parity for
and the full meeting agenda will be 2017-01-19/html/2017-01058.htm). Mental Health and Substance Use
posted on the SACHRP Web site at: The SOH will present their
Disorder Coverage
http://www.dhhs.gov/ohrp/sachrp- recommendations regarding the new
committee/meetings/index.html. Common Rule’s compliance dates and AGENCY: Assistant Secretary for
transition provisions, as well as for the Planning and Evaluation, HHS.
DATES: The meeting will be held on
interpretation and implementation of ACTION: Notice of meeting.
Tuesday, July 25, 2017, from 8:30 a.m. the broad consent provision, followed
until 5:00 p.m., and Wednesday, July by the SAS discussing their report on SUMMARY: This notice announces a
26, 2017, from 8:30 a.m. until 2:30 p.m. the interpretation of the new exemption public stakeholder listening session on
ADDRESSES: Fishers Lane Conference involving benign behavioral Strategies for Improving Parity for
Center, Terrace Level, 5635 Fishers interventions. The Tuesday, July 25, Mental Health and Substance Use
Lane, Rockville, Maryland 20852. meeting will adjourn at approximately Disorder Coverage. The public meeting,
FOR FURTHER INFORMATION CONTACT: Julia 5:00 p.m. mandated in the 21st Century Cures Act,
Gorey, J.D., Executive Director, The Wednesday, July 26, meeting will seeks public comment on improved
SACHRP, U.S. Department of Health begin at 8:30 a.m. with discussion of Federal and State coordination related
and Human Services, 1101 Wootton recommendations from the SAS to section 2726 of the Public Health
Parkway, Suite 200, Rockville, regarding the new Common Rule’s Service Act, section 712 of the
Maryland 20852; telephone: 240–453– expedited review requirements. Employee Retirement Income Security
8141; fax: 240–453–6909; email address: The meeting will adjourn at Act of 1974, section 9812 of the Internal
SACHRP@hhs.gov. approximately 2:30 p.m., July 26, 2017. Revenue Code of 1986, and any
SUPPLEMENTARY INFORMATION: Under the Time for public comment sessions will comparable provisions of State law. The
sradovich on DSK3GMQ082PROD with NOTICES
authority of 42 U.S.C. 217a, Section 222 be allotted both days. On-site public meeting will seek participation
of the Public Health Service Act, as registration is required for participation from the required stakeholders in
amended, SACHRP was established to in the live public comment session. statute, State health commissioners,
provide expert advice and Note that public comment must be State agencies, State attorneys general,
recommendations to the Secretary of relevant to issues currently being the National Association of Insurance
Health and Human Services, through addressed by the SACHRP. Individuals Commissioners, health insurance
the Assistant Secretary for Health, on submitting written statements as public issuers, providers of mental health and
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Document Created: 2018-11-14 10:19:47
Document Modified: 2018-11-14 10:19:47
| 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, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, (301) 796-7726, [email protected] | |
| FR Citation | 82 FR 30875 |
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