82 FR 24130 - 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 100 (May 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 100 (May 25, 2017)
| Page Range | 24130-24131 | |
| FR Document | 2017-10736 |
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)] [Notices] [Pages 24130-24131] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10736] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-N-0879; FDA-2013-N-0579; FDA-2016-N-2474; FDA- 2016-D-1853; FDA-2013-N-0764; FDA-2013-N-0825; FDA-2013-N-0797; FDA- 2013-N-0578] 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, 11601 Landsdown Street, 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 24131]] Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Procedures for the Safe Processing and 0910-0354 2/29/2020 Importing of Fish and Fishery Products. Biological Products: Reporting of 0910-0458 2/29/2020 Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue- Based Product Deviations; Form FDA 3486 and Addendum, 3486A.................... Designation of New Animal Drugs for 0910-0605 2/29/2020 Minor Use or Minor Species............. Unique Device Identification System..... 0910-0720 2/29/2020 Animal Feed Regulatory Program Standards 0910-0760 2/29/2020 Premarket Approval of Medical Devices-- 0910-0231 3/31/2020 21 CFR Part 814........................ Human Tissue Intended for 0910-0302 3/31/2020 Transplantation........................ General Licensing Provisions: Biological 0910-0338 3/31/2020 License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h................................... ------------------------------------------------------------------------ Dated: May 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislative, and Analysis. [FR Doc. 2017-10736 Filed 5-24-17; 8:45 am] BILLING CODE 4164-01-P
![24130 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
2. Form CMS–20017 with complete Guard Service personnel before entering that is, reporting, recordkeeping, or
contact information that includes name, the building. Without a current, valid third-party disclosure requirements.
address, phone number, and email photo ID, persons may not be permitted Consequently, there is no need for
addresses for all presenters and entry to the building. review by the Office of Management and
commenters and a contact person that • Security measures include Budget under the authority of the
can answer any questions, and provide inspection of vehicles, inside and out, at Paperwork Reduction Act of 1995 (44
revisions that are requested, for the the entrance to the grounds. U.S.C. 3501 et seq.).
presentation. Presenters and • All persons entering the building
Dated: May 18, 2017.
commenters must clearly explain the must pass through a metal detector.
• All items brought into CMS, Seema Verma,
actions that they are requesting CMS to
including personal items, for example, Administrator, Centers for Medicare &
take in the appropriate section of the Medicaid Services.
form. A presenter’s or commenter’s laptops and cell phones, are subject to
physical inspection. [FR Doc. 2017–10683 Filed 5–24–17; 8:45 am]
relationship with the organization that
they represent must also be clearly • The public may enter the building BILLING CODE 4120–01–P
listed. 30 to 45 minutes before the meeting
• The form is now available through convenes each day.
the CMS Forms Web site at: https:// • All visitors must be escorted in DEPARTMENT OF HEALTH AND
areas other than the lower and first-floor HUMAN SERVICES
www.cms.gov/Medicare/CMS-Forms/
CMS-Forms/downloads/cms20017.pdf. levels in the Central Building.
• The main-entrance guards will Food and Drug Administration
• We encourage presenters to make
efforts to ensure that their presentations issue parking permits and instructions
and comments are 508 compliant. upon arrival at the building. [Docket Nos. FDA–2013–N–0879; FDA–
• Foreign nationals visiting any CMS 2013–N–0579; FDA–2016–N–2474; FDA–
IV. Oral Comments facility require prior approval. If you are 2016–D–1853; FDA–2013–N–0764; FDA–
a foreign national and wish to attend the 2013–N–0825; FDA–2013–N–0797; FDA–
In addition to formal oral 2013–N–0578]
presentations, which are limited to 5 meeting onsite, in addition to registering
minutes total per presentation, there for the meeting, you must also send a Agency Information Collection
will be an opportunity during the separate email to APCPanel@ Activities; Announcement of Office of
meeting for public oral comments, cms.hhs.gov prior to the close of Management and Budget Approvals
which will be limited to 1 minute for registration to request authorization to
each individual and a total of 3 minutes attend as a foreign national. AGENCY: Food and Drug Administration,
per organization. Note: As of March 30, 2015, the ‘‘Real ID HHS.
Act’’ requires a second form of identification ACTION: Notice.
V. Meeting Attendance from those whose government issued photo
The meeting is open to the public; identification or government issued driver’s SUMMARY: The Food and Drug
however, attendance is limited to space license was issued by American Samoa,
Administration (FDA) is publishing a
Arizona, Louisiana, Maine, Minnesota, and
available. Priority will be given to those New York. Attendees with a government list of information collections that have
who pre-register and attendance may be issued photo identification or driver’s license been approved by the Office of
limited based on the number of issued by the states previously mentioned Management and Budget (OMB) under
registrants and the space available. may need to provide alternative or additional the Paperwork Reduction Act of 1995.
Persons wishing to attend this approved proof of identification in order to
FOR FURTHER INFORMATION CONTACT: Ila
meeting, which is located on federal comply with the ‘‘Real ID Act.’’
S. Mizrachi, Office of Operations, Food
property, must register by following the and Drug Administration, Three White
instructions in the DATES section of this VII. Special Accommodations
Flint North, 11601 Landsdown Street,
notice under ‘‘Meeting Registration Individuals requiring special North Bethesda, MD 20852, 301–796–
Timeframe’’. A confirmation email will accommodations must include the 7726, PRAStaff@fda.hhs.gov.
be sent to the registrants shortly after request for these services during
completing the registration process. SUPPLEMENTARY INFORMATION: The
registration.
following is a list of FDA information
VI. Security, Building, and Parking VIII. Panel Recommendations and collections recently approved by OMB
Guidelines Discussions under section 3507 of the Paperwork
The following are the security, The Panel’s recommendations at any Reduction Act of 1995 (44 U.S.C. 3507).
building, and parking guidelines: Panel meeting generally are not final The OMB control number and
• Persons attending the meeting, until they have been reviewed and expiration date of OMB approval for
including presenters, must be pre- approved by the Panel on the last day each information collection are shown
registered and on the attendance list by of the meeting, before the final in table 1. Copies of the supporting
the prescribed date. adjournment. These recommendations statements for the information
• Individuals who are not pre- will be posted to our Web site after the collections are available on the Internet
registered in advance may not be meeting. at https://www.reginfo.gov/public/do/
permitted to enter the building and may PRAMain. An Agency may not conduct
be unable to attend the meeting. IX. Collection of Information or sponsor, and a person is not required
• Attendees must present a Requirements to respond to, a collection of
government-issued photo identification This document does not impose information unless it displays a
to the Federal Protective Service or information collection requirements, currently valid OMB control number.
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![Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 24131
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................ 0910–0354 2/29/2020
Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A ..................................................... 0910–0458 2/29/2020
Designation of New Animal Drugs for Minor Use or Minor Species ....................................................................... 0910–0605 2/29/2020
Unique Device Identification System ....................................................................................................................... 0910–0720 2/29/2020
Animal Feed Regulatory Program Standards ......................................................................................................... 0910–0760 2/29/2020
Premarket Approval of Medical Devices—21 CFR Part 814 .................................................................................. 0910–0231 3/31/2020
Human Tissue Intended for Transplantation ........................................................................................................... 0910–0302 3/31/2020
General Licensing Provisions: Biological License Application, Changes to an Approved Application, Labeling,
Revocation and Suspension, and Form FDA 356h ............................................................................................. 0910–0338 3/31/2020
Dated: May 18, 2017. and Drug Administration, Three White other public health emergencies. By
Anna K. Abram, Flint North, 10A63, 11601 Landsdown requiring that a prior notice contain
Deputy Commissioner for Policy, Planning, St., North Bethesda, MD 20852, 301– additional information that indicates
Legislative, and Analysis. 796–7726, PRAStaff@fda.hhs.gov. prior refusals by any country and also
[FR Doc. 2017–10736 Filed 5–24–17; 8:45 am] SUPPLEMENTARY INFORMATION: In identifies the country or countries, the
BILLING CODE 4164–01–P compliance with 44 U.S.C. 3507, FDA Agency may better identify imported
has submitted the following proposed food shipments that may pose safety
collection of information to OMB for and security risks to U.S. consumers.
DEPARTMENT OF HEALTH AND review and clearance. This additional knowledge can further
HUMAN SERVICES help FDA to make better informed
Prior Notice of Imported Food Under decisions in managing the potential
Food and Drug Administration the Public Health Security and risks of imported food shipments into
Bioterrorism Preparedness and the United States.
[Docket No. FDA–2010–N–0118]
Response Act of 2002—21 CFR 1.278 to Any person with knowledge of the
Agency Information Collection 1.285, OMB Control Number 0910–0520 required information may submit prior
Activities; Submission for Office of The Public Health Security and notice for an article of food. Thus, the
Management and Budget Review; Bioterrorism Preparedness and respondents to this information
Comment Request; Prior Notice of Response Act of 2002 (the Bioterrorism collection may include importers,
Imported Food Under the Public Health Act) added section 801(m) of the owners, ultimate consignees, shippers,
Security and Bioterrorism Federal Food, Drug, and Cosmetic Act and carriers.
Preparedness and Response Act of (the FD&C Act) (21 U.S.C. 381(m)), FDA regulations require that prior
2002 which requires that FDA receives prior notice of imported food be submitted
AGENCY: Food and Drug Administration, notice for food, including food for electronically using CBP’s Automated
HHS. animals, that is imported or offered for Broker Interface of the Automated
import into the United States. Sections Commercial System (ABI/ACS)
ACTION: Notice. 1.278 to 1.282 of FDA regulations (21 (§ 1.280(a)(1)) or the FDA Prior Notice
SUMMARY: The Food and Drug CFR 1.278 to 1.282) set forth the System Interface (PNSI) (Form FDA
Administration (FDA) is announcing requirements for submitting prior 3540) (§ 1.280(a)(2)). PNSI is an
that a proposed collection of notice; §§ 1.283(d) and 1.285(j) (21 CFR electronic submission system available
information has been submitted to the 1.283(d) and 1.285(j)) set forth the on the FDA Industry Systems page at
Office of Management and Budget procedure for requesting the Agency https://www.access.fda.gov/.
(OMB) for review and clearance under review after FDA has refused admission Information the Agency collects in the
the Paperwork Reduction Act of 1995. of an article of food under section prior notice submission includes: (1)
DATES: Fax written comments on the
801(m)(1) of the FD&C Act or placed an The submitter and transmitter (if
collection of information by June 26, article of food under hold under section different from the submitter); (2) entry
2017. 801(l); and § 1.285(i) sets forth the type and CBP identifier; (3) the article
procedure for post-hold submissions. of food, including complete FDA
ADDRESSES: To ensure that comments on Section 304 of the FDA Food Safety product code; (4) the manufacturer, for
the information collection are received, Modernization Act (FSMA) (Pub. L. an article of food no longer in its natural
OMB recommends that written 111–353) amended section 801(m) of the state; (5) the grower, if known, for an
comments be faxed to the Office of FD&C Act to require a person submitting article of food that is in its natural state;
Information and Regulatory Affairs, prior notice of imported food, including (6) the FDA Country of Production; (7)
OMB, Attn: FDA Desk Officer, FAX: food for animals, to report, in addition the name of any country that has
202–395–7285, or emailed to oira_ to other information already required, refused entry of the article of food; (8)
submission@omb.eop.gov. All ‘‘any country to which the article has the shipper, except for food imported by
comments should be identified with the been refused entry.’’ international mail; (9) the country from
OMB control number 0910–0520. Also Advance notice of imported food which the article of food is shipped or,
include the FDA docket number found allows FDA, with the support of the if the food is imported by international
in brackets in the heading of this U.S. Customs and Border Protection mail, the anticipated date of mailing and
document. (CBP), to target import inspections more country from which the food is mailed;
FOR FURTHER INFORMATION CONTACT: Ila effectively and help protect the nation’s (10) the anticipated arrival information
S. Mizrachi, Office of Operations, Food food supply against terrorist acts and or, if the food is imported by
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Document Created: 2018-11-08 08:52:23
Document Modified: 2018-11-08 08:52:23
| 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, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 24130 |
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