82_FR_19136 82 FR 19058 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing

82 FR 19058 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range19058-19059
FR Document2017-08305

The Food and Drug Administration (FDA) is announcing that two collections of information: ``Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' and ``Blood Establishment Registration and Product Listing'' have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19058-19059]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Establishment Registration of 
Producers of Drugs and Listing of Drugs in Commercial Distribution and 
Blood Establishment Registration and Product Listing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that two 
collections of information: ``Establishment Registration of Producers 
of Drugs and Listing of Drugs in Commercial Distribution'' and ``Blood 
Establishment Registration and Product Listing'' have been approved by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: On December 16, 2016, the Agency submitted 
proposed collections of information entitled ``Establishment 
Registration of Producers of Drugs and Listing of Drugs in Commercial 
Distribution'' and ``Blood Establishment Registration and Product 
Listing'' to

[[Page 19059]]

OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has 
assigned OMB control numbers 0910-0045 and 0910-0052, respectively. The 
information collection 0910-0045 expires on December 31, 2018, and the 
information collection 0910-0052 expires May 31, 2018. Copies of the 
supporting statements for the information collections are available on 
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08305 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P

19058 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices information as ‘‘confidential.’’ Any summary of the public comments at least 7 days in advance of the information marked as ‘‘confidential’’ received concerning whether the meeting. will not be disclosed except in protocol should proceed as modified, FDA is committed to the orderly accordance with 21 CFR 10.20 and other the committee will discuss the protocol conduct of its advisory committee applicable disclosure law. For more modification and develop a meetings. Please visit our Web site at information about FDA’s posting of recommendation regarding whether the http://www.fda.gov/ comments to public dockets, see 80 FR protocol should proceed as modified. AdvisoryCommittees/ 56469, September 18, 2015, or access The committee’s recommendation will AboutAdvisoryCommittees/ the information at: https://www.gpo.gov/ then be presented to the Commissioner ucm111462.htm for procedures on fdsys/pkg/FR-2015-09-18/pdf/2015- of Food and Drugs. public conduct during advisory 23389.pdf. FDA intends to make background committee meetings. Docket: For access to the docket to material available to the public no later Notice of this meeting is given under read background documents or the than 2 business days before the meeting. the Federal Advisory Committee Act (5 electronic and written/paper comments If FDA is unable to post the background U.S.C. app. 2). received, go to https:// material on its Web site prior to the Dated: April 19, 2017. www.regulations.gov and insert the meeting, the background material will Anna K. Abram, docket number, found in brackets in the be made publicly available at the Deputy Commissioner for Policy, Planning, heading of this document, into the location of the advisory committee Legislation, and Analysis. ‘‘Search’’ box and follow the prompts meeting, and the background material [FR Doc. 2017–08299 Filed 4–24–17; 8:45 am] and/or go to the Division of Dockets will be posted on FDA’s Web site after BILLING CODE 4164–01–P Management, 5630 Fishers Lane, Rm. the meeting. Background material will 1061, Rockville, MD 20852. be available at: http://www.fda.gov/ FOR FURTHER INFORMATION CONTACT: AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND Marieann Brill, Office of the default.htm. Scroll down to the HUMAN SERVICES Commissioner, Food and Drug appropriate advisory committee meeting Administration, 10903 New Hampshire link. Food and Drug Administration Ave., Bldg. 32, Rm. 5154, Silver Spring, Procedure: Interested persons may [Docket No. FDA–2005–N–0464 (Formerly MD 20993, 240–402–3838, email: present data, information, or views, Docket No. 2005N–0403)] marieann.brill@fda.hhs.gov, or FDA orally or in writing, on issues pending Advisory Committee Information Line, before the committee. Written Agency Information Collection 1–800–741–8138 (301–443–0572 in the submissions may be made to the contact Activities; Announcement of Office of Washington, DC area). A notice in the person on or before May 11, 2017. Oral Management and Budget Approval; Federal Register about last minute presentations from the public will be Establishment Registration of modifications that impact a previously scheduled on May 18, 2017 between Producers of Drugs and Listing of announced advisory committee meeting approximately 11 a.m. and 12:30 p.m. Drugs in Commercial Distribution and cannot always be published quickly Those individuals interested in making Blood Establishment Registration and enough to provide timely notice. formal oral presentations should notify Product Listing Therefore, you should always check the the contact person and submit a brief Agency’s Web site at http:// statement of the general nature of the AGENCY: Food and Drug Administration, www.fda.gov/AdvisoryCommittees/ evidence or arguments they wish to HHS. default.htm. Scroll down to the present, the names and addresses of ACTION: Notice. appropriate advisory committee meeting proposed participants, and an link, or call the advisory committee indication of the approximate time SUMMARY: The Food and Drug information line to learn about possible requested to make their presentation on Administration (FDA) is announcing modifications before coming to the or before May 3, 2017. Time allotted for that two collections of information: meeting. each presentation may be limited. If the ‘‘Establishment Registration of number of registrants requesting to Producers of Drugs and Listing of Drugs SUPPLEMENTARY INFORMATION: in Commercial Distribution’’ and Agenda: On May 18, 2017, the PAC speak is greater than can be reasonably accommodated during the scheduled ‘‘Blood Establishment Registration and and the PES will meet to discuss a Product Listing’’ have been approved by referral by an Institutional Review open public hearing session, FDA may conduct a lottery to determine the the Office of Management and Budget Board (IRB) of a clinical investigation (OMB) under the Paperwork Reduction that involves children and FDA speakers for the scheduled open public hearing session. The contact person will Act of 1995. regulated products. The clinical notify interested persons regarding their FOR FURTHER INFORMATION CONTACT: investigation is entitled ‘‘A Double- Blind, Placebo-Controlled, Multi-Center request to speak by May 4, 2017. JonnaLynn Capezzuto, Office of Study with an Open-Label Extension to Persons attending FDA’s advisory Operations, Food and Drug Evaluate the Efficacy and Safety of SRP– committee meetings are advised that the Administration, Three White Flint 4045 and SRP–4053 in Patients with Agency is not responsible for providing North 10A–12M, 11601 Landsdown St., Duchenne Muscular Dystrophy.’’ access to electrical outlets. North Bethesda, MD 20852, 301–796– Comments about the upcoming joint For press inquiries, please contact the 3794. asabaliauskas on DSK3SPTVN1PROD with NOTICES meeting should be submitted to Docket Office of Media Affairs at fdaoma@ SUPPLEMENTARY INFORMATION: On No. FDA 2017–N–1780. fda.hhs.gov or 301–796–4540. December 16, 2016, the Agency After presentation of an overview of FDA welcomes the attendance of the submitted proposed collections of the IRB referral process under 21 CFR public at its advisory committee information entitled ‘‘Establishment 50.54, an overview of the protocol and meetings and will make every effort to Registration of Producers of Drugs and the issues raised by the IRB referral, accommodate persons with disabilities. Listing of Drugs in Commercial other relevant presentations about the If you require accommodations due to a Distribution’’ and ‘‘Blood Establishment request to modify the protocol, and a disability, please contact Marieann Brill Registration and Product Listing’’ to VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19059 OMB for review and clearance under 44 DATES: The public workshop will be Written/Paper Submissions U.S.C. 3507. An Agency may not held on May 18 and 19, 2017, from 8 Submit written/paper submissions as conduct or sponsor, and a person is not a.m. to 6 p.m. Submit either electronic follows: required to respond to, a collection of or written comments on the public • Mail/Hand delivery/Courier (for information unless it displays a workshop by June 23, 2017. Late written/paper submissions): Division of currently valid OMB control number. untimely filed comments will not be Dockets Management (HFA–305), Food OMB has now approved the information considered. Electronic comments must and Drug Administration, 5630 Fishers collection and has assigned OMB be submitted on or before June 23, 2017. Lane, Rm. 1061, Rockville, MD 20852. control numbers 0910–0045 and 0910– The https://www.regulations.gov/ • For written/paper comments 0052, respectively. The information electronic filing system will accept submitted to the Division of Dockets collection 0910–0045 expires on comments until midnight Eastern Time Management, FDA will post your December 31, 2018, and the information at the end of June 23, 2017. Comments comment, as well as any attachments, collection 0910–0052 expires May 31, received by mail/hand delivery/courier except for information submitted, 2018. Copies of the supporting (for written/paper submissions) will be marked and identified, as confidential, statements for the information considered timely if they are if submitted as detailed in collections are available on the Internet postmarked or the delivery service ‘‘Instructions.’’ at http://www.reginfo.gov/public/do/ acceptance receipt is on or before that Instructions: All submissions received PRAMain. date. See the SUPPLEMENTARY must include the Docket No. FDA– INFORMATION section for registration date Dated: April 18, 2017. 2017–N–1572 for ‘‘Cybersecurity of and information. Medical Devices: A Regulatory Science Anna K. Abram, ADDRESSES: The public workshop will Gap Analysis.’’ Received comments, Deputy Commissioner for Policy, Planning, be held at FDA’s White Oak Campus, those filed in a timely manner (see Legislation, and Analysis. 10903 New Hampshire Ave., Bldg. 31, DATES), will be placed in the docket and, [FR Doc. 2017–08305 Filed 4–24–17; 8:45 am] Rm. 1503 (The Great Room), Silver except for those submitted as BILLING CODE 4164–01–P Spring, MD 20993. Entrance for the ‘‘Confidential Submissions,’’ publicly public workshop participants (non-FDA viewable at https:// employees) is through Building 1 where www.regulations.gov/ or at the Division DEPARTMENT OF HEALTH AND routine security check procedures will HUMAN SERVICES of Dockets Management between 9 a.m. be performed. For parking and security and 4 p.m., Monday through Friday. Food and Drug Administration information, please refer to https:// • Confidential Submissions—To www.fda.gov/AboutFDA/ submit a comment with confidential WorkingatFDA/BuildingsandFacilities/ information that you do not wish to be [Docket No. FDA–2017–N–1572] WhiteOakCampusInformation/ made publicly available, submit your ucm241740.htm. comments only as a written/paper Cybersecurity of Medical Devices: A You may submit comments as Regulatory Science Gap Analysis; submission. You should submit two follows: Public Workshop; Request for copies total. One copy will include the Comments Electronic Submissions information you claim to be confidential Submit electronic comments in the with a heading or cover note that states AGENCY: Food and Drug Administration, ‘‘THIS DOCUMENT CONTAINS following way: HHS. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The ACTION: Notice of public workshop; https://www.regulations.gov/. Follow Agency will review this copy, including request for comments. the instructions for submitting the claimed confidential information, in comments. Comments submitted its consideration of comments. The SUMMARY: The Food and Drug electronically, including attachments, to second copy, which will have the Administration (FDA, the Agency, or https://www.regulations.gov/ will be claimed confidential information we), in association with National posted to the docket unchanged. redacted/blacked out, will be available Science Foundation (NSF) and Because your comments will be made for public viewing and posted on Department of Homeland Security, public, you are solely responsible for https://www.regulations.gov/. Submit Science and Technology (DHS S&T) is ensuring that your comments do not both copies to the Division of Dockets announcing the following public include any confidential information Management. If you do not wish your workshop entitled ‘‘Cybersecurity of that you or a third party may not wish name and contact information to be Medical Devices: A Regulatory Science to be public, such as medical made publicly available, you can Gap Analysis.’’ The objective of the information, your or anyone else’s provide this information on the cover workshop is to facilitate a discussion on Social Security number, or confidential sheet and not in the body of your the current state of regulatory science in business information, such as a comments and you must identify this the field of cybersecurity of medical manufacturing process. Please note that information as ‘‘confidential.’’ Any devices, with a focus on patient safety. if you include your name, contact information marked as ‘‘confidential’’ The purpose of this public workshop is information, or other information that will not be disclosed except in to catalyze collaboration among Health identifies you in the body of your accordance with 21 CFR 10.20 and other Care and Public Health (HPH) comments, that information will be applicable disclosure law. For more asabaliauskas on DSK3SPTVN1PROD with NOTICES stakeholders to identify regulatory posted on https://www.regulations.gov/. information about FDA’s posting of science challenges, discuss innovative • If you want to submit a comment comments to public dockets, see 80 FR strategies to address those challenges, with confidential information that you 56469, September 18, 2015, or access and encourage proactive development of do not wish to be made available to the the information at: https://www.gpo.gov/ analytical tools, processes, and best public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- practices by the stakeholder community written/paper submission and in the 23389.pdf. to strengthen medical device manner detailed (see ‘‘Written/Paper Docket: For access to the docket to cybersecurity. Submissions’’ and ‘‘Instructions’’). read background documents or the VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:12
Document Modified: 2017-04-25 02:18:12
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.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation82 FR 19058 
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