82_FR_19144 82 FR 19066 - Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference

82 FR 19066 - Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range19066-19067
FR Document2017-08308

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), together with the Center for Devices and Radiological Health (CDRH), is sponsoring a 2-day public conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry. Our primary audience is that of small manufacturers of drug and/or medical devices who want to learn about how FDA approaches the regulation of drugs and medical devices and for whom increased certainty and predictability will help to decrease the regulatory burdens that can be associated with a lack of understanding of, or familiarity with, FDA's drug and medical device regulations. However, anyone involved in the pharmaceutical and/or medical device industry may attend.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19066-19067]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Food and Drug Administration Small Business and Industry 
Assistance Regulatory Education for Industry Spring Conference; Public 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER), together with the Center for Devices 
and Radiological Health (CDRH), is sponsoring a 2-day public conference 
entitled ``FDA Small Business and Industry Assistance Regulatory 
Education for Industry (REdI) Spring Conference.'' The goal of this 
public conference is to provide direct, relevant, and helpful 
information on the key aspects of drug and medical device regulations 
in order to increase regulatory certainty and predictability for 
pharmaceutical and/or medical device industry. Our primary audience is 
that of small manufacturers of drug and/or medical devices who want to 
learn about how FDA approaches the regulation of drugs and medical 
devices and for whom increased certainty and predictability will help 
to decrease the regulatory burdens that can be associated with a lack 
of understanding of, or familiarity with, FDA's drug and medical device 
regulations. However, anyone involved in the pharmaceutical and/or 
medical device industry may attend.

DATES: The public conference will be held May 9 and 10, 2017, from 8:30 
a.m. to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration information.

ADDRESSES: The public conference will be held in the High Ballroom, 
located on the Lobby Level of the Renaissance Atlanta Midtown Hotel, 
866 W. Peachtree St. NW., Atlanta, GA 30308. The hotel's phone number 
is 678-412-2400.

FOR FURTHER INFORMATION CONTACT: Brenda Stodart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, email: 
[email protected]; or Elias Mallis, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7100, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a public conference entitled ``FDA Small Business 
and Industry Assistance Regulatory Education for Industry Spring 
Conference.'' This public conference is intended to increase the drug 
and medical device industry's awareness of applicable FDA regulations. 
There will be an opportunity for questions and answers following each 
presentation.

II. Topics for Discussion at the Conference

    This 2-day, FDA-led forum offers the opportunity to interact with 
FDA subject matter experts from across CDER and CDRH. The following 
information will be discussed:

 CDER Investigational New Drug Application (IND) Review 
Process: Types of IND; Content and Format of an IND; Chemistry 
Manufacturing and Controls; Pharmacology/Toxicology; Drug Inspections
 CDRH: 510(k); Biocompatibility in Premarket Submissions; Non-
Conforming Product; Device Inspections

III. Participating in the Public Conference

    Registration: There is no fee to attend the public conference. 
Space is limited, and registration will be on a first-come, first-
served basis. To register, please complete registration online at: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm545309.htm. Early registration is 
recommended. Registrants will receive email confirmation when they have 
been accepted, and reminder emails will be sent to registrants 2 days 
before the conference. If time and space permit, onsite registration 
will be available beginning at 7:30 a.m. on each day of the public 
conference. If you need special accommodations due to disability, 
please contact [email protected] at least 7 days in advance.
    Streaming Webcast of the Public Conference: This public conference 
will also be Webcast. Persons interested in viewing the Webcast must 
register to

[[Page 19067]]

receive a confirmation email with the Webcast link.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Transcripts will not be available.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08308 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P

19066 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices NIH and placed in a public docket Dated: April 19, 2017. Drug Administration, 10001 New assigned by FDA. Anna K. Abram, Hampshire Ave., Silver Spring, MD Neonates are at risk for serious Deputy Commissioner for Policy, Planning, 20993–0002, 301–796–6707, email: bacterial infections including Legislation, and Analysis. cdersbia@fda.hhs.gov; or Elias Mallis, meningitis, bacteremia, sepsis, and [FR Doc. 2017–08301 Filed 4–24–17; 8:45 am] Center for Devices and Radiological urinary tract infections. Most of these BILLING CODE 4164–01–P Health, 10903 New Hampshire Ave., children are admitted to a hospital, Silver Spring, MD 20993–0002, 301– where they receive antibiotics. Early 796–7100, email: DICE@fda.hhs.gov. onset of bacterial infection (less than 7 DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: days of life) reflects vertical HUMAN SERVICES I. Background transmission, usually caused by group B Food and Drug Administration streptococci (GBS), Escherichia coli, FDA is announcing a public Listeria monocytogenes, or enterococcus [Docket No. FDA–2017–N–0001] conference entitled ‘‘FDA Small species, and is a significant cause of Business and Industry Assistance illness and death among low birth Food and Drug Administration Small Regulatory Education for Industry weight infants. Late onset infections Business and Industry Assistance Spring Conference.’’ This public suggest nosocomial, community- Regulatory Education for Industry conference is intended to increase the acquired infections or late onset GBS; Spring Conference; Public Conference drug and medical device industry’s these may be caused by gram-negative awareness of applicable FDA AGENCY: Food and Drug Administration, organisms as well as staphylococcal regulations. There will be an HHS. species. The first line of antibiotic opportunity for questions and answers ACTION: Notice of public conference. following each presentation. therapy is ampicillin in combination with gentamicin or a third-generation SUMMARY: The Food and Drug II. Topics for Discussion at the cephalosporin. Administration (FDA) Center for Drug Conference Evaluation and Research (CDER), In the Federal Register of February This 2-day, FDA-led forum offers the together with the Center for Devices and 13, 2004 (71 FR 23931), NIH published opportunity to interact with FDA Radiological Health (CDRH), is a notice announcing the addition of subject matter experts from across CDER sponsoring a 2-day public conference several drugs, including ampicillin, to and CDRH. The following information entitled ‘‘FDA Small Business and the priority list of drugs most in need of will be discussed: Industry Assistance Regulatory study for use by children to ensure the • CDER Investigational New Drug Education for Industry (REdI) Spring drugs’ safety and efficacy. A written Application (IND) Review Process: Conference.’’ The goal of this public request for pediatric studies of Types of IND; Content and Format of conference is to provide direct, relevant, ampicillin was issued on August 5, an IND; Chemistry Manufacturing and and helpful information on the key 2005, to the holders of applications for Controls; Pharmacology/Toxicology; aspects of drug and medical device ampicillin. FDA did not receive a Drug Inspections regulations in order to increase response to the written request. • CDRH: 510(k); Biocompatibility in regulatory certainty and predictability Accordingly, NIH issued a request for Premarket Submissions; Non- for pharmaceutical and/or medical proposals to conduct the pediatric Conforming Product; Device device industry. Our primary audience studies described in the written request Inspections is that of small manufacturers of drug in 2006, and awarded funds to Pediatric and/or medical devices who want to III. Participating in the Public Trials Network in December 2011 to learn about how FDA approaches the Conference complete the studies described in the regulation of drugs and medical devices written request. Upon completion of the Registration: There is no fee to attend and for whom increased certainty and pediatric studies, a report of the the public conference. Space is limited, predictability will help to decrease the pediatric studies of ampicillin was and registration will be on a first-come, regulatory burdens that can be submitted to NIH and FDA. As required first-served basis. To register, please associated with a lack of understanding under section 409I of the PHS Act, FDA complete registration online at: https:// of, or familiarity with, FDA’s drug and opened a public docket and NIH placed www.fda.gov/Drugs/ medical device regulations. However, in the docket the report of pediatric DevelopmentApprovalProcess/ anyone involved in the pharmaceutical studies of ampicillin that was submitted SmallBusinessAssistance/ and/or medical device industry may to NIH and FDA. The report includes all ucm545309.htm. Early registration is attend. data generated in connection with the recommended. Registrants will receive study, including the written request. DATES: The public conference will be email confirmation when they have held May 9 and 10, 2017, from 8:30 a.m. II. Availability of Report for Public been accepted, and reminder emails will to 4:30 p.m. See the SUPPLEMENTARY Comment be sent to registrants 2 days before the INFORMATION section for registration conference. If time and space permit, information. FDA is announcing the 30-day open onsite registration will be available public comment period for the report of ADDRESSES: The public conference will beginning at 7:30 a.m. on each day of the pediatric studies of ampicillin that be held in the High Ballroom, located on the public conference. If you need asabaliauskas on DSK3SPTVN1PROD with NOTICES were conducted in accordance with the Lobby Level of the Renaissance special accommodations due to section 409I of the PHS Act and Atlanta Midtown Hotel, 866 W. disability, please contact info@ submitted to NIH and FDA. We invite Peachtree St. NW., Atlanta, GA 30308. sbiaevents.com at least 7 days in interested parties to review the Duke The hotel’s phone number is 678–412– advance. Clinical Research Institute report, which 2400. Streaming Webcast of the Public was posted to the docket on December FOR FURTHER INFORMATION CONTACT: Conference: This public conference will 15, 2015, and submit comments to the Brenda Stodart, Center for Drug also be Webcast. Persons interested in docket (see ADDRESSES). Evaluation and Research, Food and viewing the Webcast must register to VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19067 receive a confirmation email with the ADDRESSES: Submit your comments, formula-based criteria used to determine Webcast link. including the Information Collection the award amount to the applicant If you have never attended a Connect Request Title, to the desk officer for schools. Continued approval of the Pro event before, test your connection at HRSA, either by email to OIRA_ revised NFLP—Program Specific Data https://collaboration.fda.gov/common/ submission@omb.eop.gov or by fax to Form allows HRSA to efficiently capture help/en/support/meeting_test.htm. To 202–395–5806. data to generate the formula-based get a quick overview of the Connect Pro FOR FURTHER INFORMATION CONTACT: To award and facilitates reporting on the program, visit https://www.adobe.com/ request a copy of the clearance requests use of funds and analysis of program go/connectpro_overview. FDA has submitted to OMB for review, email the outcomes. verified the Web site addresses in this HRSA Information Collection Clearance The addition of Line Item D2, NFLP document, as of the date this document Officer at paperwork@hrsa.gov or call Loan Fund Default Rate, will allow publishes in the Federal Register, but (301) 443–1984. HRSA to easily assess and consider an Web sites are subject to change over SUPPLEMENTARY INFORMATION: When existing performance standard for those time. submitting comments or requesting Transcripts: Transcripts will not be applicants with existing NFLP loan information, please include the accounts. Used in combination with an available. information request collection title for existing NFLP institution’s self-reported Dated: April 19, 2017. reference, in compliance with Section NFLP loan balance, the addition of Line Anna K. Abram, 3506(c)(2)(A) of the Paperwork Item D3, Last NFLP Student Loan Deputy Commissioner for Policy, Planning, Reduction Act of 1995. Award, will allow HRSA to assess the Legislation, and Analysis. Information Collection Request Title: loan fund activity (i.e., incidence of [FR Doc. 2017–08308 Filed 4–24–17; 8:45 am] Nurse Faculty Loan Program (NFLP)— loans to students) of an existing NFLP BILLING CODE 4164–01–P Program Specific Data Form, OMB No. institution applying for additional 0915–0378—Revision. funding. Abstract: This clearance request is for DEPARTMENT OF HEALTH AND continued approval of the Nurse Faculty Likely Respondents: NFLP eligible HUMAN SERVICES Loan Program (NFLP) revised Program applicants. This includes accredited Specific Data Form. HRSA is schools of nursing offering eligible Health Resources and Services streamlining the data collection form by advanced masters and/or doctoral Administration making the following changes: degree nursing education programs that [OMB No. 0915–0378] • Line Item D will be renamed ‘‘D1. will prepare students to serve as NFLP Loan Fund Balance/Unused qualified nursing faculty. Agency Information Collection Accumulation.’’ Burden Statement: Burden in this Activities: Submission to OMB for • Addition of Line Item D2 titled context means the time expended by Review and Approval; Public Comment ‘‘NFLP Loan Fund Default Rate,’’ persons to generate, maintain, retain, Request; Information Collection Title: requesting information regarding the disclose or provide the information Nurse Faculty Loan Program (NFLP)— status of an institution’s default rate. requested. This includes the time Program Specific Data Form; Revision • Addition of Line Item D3 titled needed to review instructions; to ‘‘Last NFLP Student Loan Award,’’ develop, acquire, install, and utilize AGENCY: Health Resources and Services requesting information regarding the technology and systems for the purpose Administration (HRSA), Department of disbursement of NFLP loan funds of collecting, validating, and verifying Health and Human Services. within the last 2 academic years. information, processing and ACTION: Notice. • Line Item E2 Column Header will maintaining information, and disclosing be renamed ‘‘E.2 NFLP Enrollees SUMMARY: In compliance with the and providing information; to train Information by Degree—New Students Paperwork Reduction Act of 1995, personnel and to be able to respond to Expected to Request NFLP Support.’’ HRSA has submitted an Information • Under Section B of instructions, a collection of information; to search Collection Request (ICR) to the Office of ‘‘other attachments’’ will be updated to data sources; to complete and review Management and Budget (OMB) for reflect the current list of NFLP Funding the collection of information; and to review and approval. Comments Opportunity Announcement transmit or otherwise disclose the submitted during the first public review attachments. information. of this ICR will be provided to OMB. Need and Proposed Use of the The total burden for this revised form OMB will accept further comments from Information: The NFLP—Program has decreased by 480 hours due to an the public during the review and Specific Data Form is a required estimated decrease in number of approval period. electronic attachment within the NFLP respondents. The total annual burden DATES: Comments on this ICR should be application materials. The data hours estimated for this ICR are received no later than May 25, 2017. provided in the form is essential for the summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of Average Number of responses Total burden per Total burden asabaliauskas on DSK3SPTVN1PROD with NOTICES Form name respondents per responses response hours respondent (in hours) NFLP—Program Specific Data Form .................................. 90 1 90 8 720 Total Burden ................................................................. 90 ........................ 90 ........................ 720 VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:24
Document Modified: 2017-04-25 02:18:24
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 of public conference.
DatesThe public conference will be held May 9 and 10, 2017, from 8:30 a.m. to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for registration information.
ContactBrenda Stodart, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, email: [email protected]; or Elias Mallis, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 301-796-7100, email: [email protected]gov.
FR Citation82 FR 19066 
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