80 FR 11966 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 43 (March 5, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 43 (March 5, 2015)
| Page Range | 11966-11968 | |
| FR Document | 2015-05018 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Proposed Rules] [Pages 11966-11968] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05018] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2014-N-1168] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public hearing that will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2016 Regulatory Science Plan. DATES: The public hearing will be held on June 5, 2015, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. ADDRESSES: The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Registration and Requests for Oral Presentations: The FDA Conference Center at the White Oak location is a [[Page 11967]] Federal facility with security procedures and limited seating. Attendance will be free and on a first-come, first-served basis. If you wish to attend (either in person or by Webcast (see Streaming Webcast of the Public Hearing)) and/or present at the hearing, please register for the hearing and/or make a request for oral presentations or comments by email to [email protected] by May 15, 2015. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and priority number(s)). Those without email access can register by contacting Thushi Amini by May 15, 2015 (see For Further Information Contact). FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the topic, or topics, they wish to address (see section V under Supplementary Information). This will help FDA organize the presentations. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Once FDA notifies registered presenters of their scheduled times, they are encouraged to submit an electronic copy of their presentation to [email protected] on or before May 22, 2015. Persons registered to make an oral presentation are encouraged to arrive at the hearing room early and check in at the onsite registration table to confirm their designated presentation time. An agenda for the hearing and other background materials will be made available 5 days before the hearing at http://www.fda.gov/GDUFARegScience. If you need special accommodations because of a disability, please contact Thushi Amini (see For Further Information Contact) at least 7 days before the hearing. Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live Webcast of the hearing. To join the hearing via the Webcast, please go to https://collaboration.fda.gov/gdufa2012/. Comments: Regardless of attendance at the public hearing, interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), 5600 Fishers Lane, Rm. 1061, Rockville, MD 20857. The deadline for submitting comments to the docket is June 26, 2015. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov or http://www.fda.gov/GDUFARegScience. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4728, Silver Spring, MD 20993; 240-402- 7958, email: [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In July 2012, Congress passed GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and reduce costs to industry. To support this goal, FDA agreed in the GDUFA commitment letter to work with industry and interested stakeholders on identifying regulatory science research priorities specific to generic drugs for each fiscal year covered by GDUFA. The commitment letter outlines FDA's performance goals and procedures under the GDUFA program for the years 2012-2017. The commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf. II. FY 2013 Regulatory Science Priorities The FY 2013 regulatory science research priorities list was developed by FDA and industry and included in the GDUFA commitment letter. To implement the FY 2013 priorities list, the Office of Generic Drugs awarded $17 million in external contracts and grants to initiate new research studies during FY 2013. Four million dollars were allocated to support internal research related to generic drugs. This includes rapid response capabilities through equipment for FDA labs and support for laboratory research fellows at FDA, as well as research fellows to work on data analysis and coordination of internal activities with external grants and contracts. III. FY 2014 Regulatory Science Priorities On June 21, 2013, the Office of Generic Drugs held a public hearing to gain input in developing the FY 2014 regulatory science priorities list. This list was prepared based on internal Center for Drug Evaluation and Research discussions, comments received from this public hearing, and comments submitted to the public docket. The FY 2014 priorities list can be found at http://www.fda.gov/GDUFARegScience. To implement the FY 2014 priorities list, the Office of Generic Drugs awarded $17 million in external contracts and grants to initiate new research studies during FY 2014. A list of FY 2014 awarded studies can be found at http://www.fda.gov/GDUFARegScience. IV. FY 2015 Regulatory Science Priorities On May 16, 2014, the Office of Generic Drugs held a public meeting to allow public input in developing the FY 2015 regulatory science priorities list. The FY 2015 Regulatory Science Priorities are as follows: 1. Postmarket Evaluation of Generic Drugs 2. Equivalence of Complex Products 3. Equivalence of Locally Acting Products 4. Therapeutic Equivalence Evaluation and Standards 5. Computational and Analytical Tools For more information on these topic areas, please visit www.fda.gov/GDUFARegScience. The Office of Generic Drugs is currently developing research studies to support the FY 2015 priorities list. Funding opportunities for collaborations will be posted in March 2015 at www.fda.gov/GDUFARegScience. V. Purpose and Scope of the June 5, 2015, Public Hearing The purpose of the June public hearing is to obtain input from industry and other interested stakeholders on the identification of regulatory science priorities for FY 2016. To help fulfill FDA's mission, FDA is particularly interested in receiving input on the following topics: [[Page 11968]] 1. Opportunities for scientific or technical advancements that would help to overcome specific barriers for industry that currently limit the availability of generic drug products. 2. Innovative approaches to preapproval development of generic drugs, including new methodologies for design and conduct of in vitro, ex vivo, and clinical studies and identification of scientifically robust strategies for demonstration of bioequivalence for various product classes. 3. Innovations in scientific approaches to evaluating the therapeutic equivalence of generic drug products through later stages of their lifecycle following initial approval. 4. Identification of high-impact public health issues involving generic drugs that can be addressed by the prioritized allocation of FY 2016 funding for regulatory science research. 5. Identification of specific issues related to generic drug products where scientific recommendations and/or clarifications are needed in developing and/or revising FDA's guidance for industry. 6. Strategies for enhancing quality and equivalence risk management during generic drug product development, during regulatory review, and/ or throughout the drug product's lifecycle following initial approval. FDA will consider all comments made at this hearing or received through the docket (see Comments under ADDRESSES) as it develops its FY 2016 GDUFA Regulatory Science Plan. Additional information concerning GDUFA, including the text of the law and the commitment letter, can be found at http://www.fda.gov/gdufa. VI. Notice of Hearing Under 21 CFR Part 15 The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with 21 CFR part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner and the Center for Drug Evaluation and Research. Under Sec. 15.30(f) (21 CFR 15.30), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may pose questions; they may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under Sec. 10.205 (21 CFR 10.205), representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in Sec. 15.30(b) (see Transcripts under ADDRESSES). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in Sec. 15.30(h). Dated: February 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05018 Filed 3-4-15; 8:45 am] BILLING CODE 4164-01-P
![11966 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Proposed Rules
paragraphs (g)(1) through (g)(5) of this AD, or method of compliance (AMOC) in Issued in Renton, Washington, on February
within 30 days after the effective date of this accordance with the procedures specified in 3, 2015.
AD, whichever occurs later. Accomplishing paragraph (k)(1) of this AD. Dionne Palermo,
this revision terminates the life limit required Acting Manager, Transport Airplane
by paragraph (n)(1) of AD 2014–23–15, (j) Parts Installation Limitation
Directorate, Aircraft Certification Service.
Amendment 39–18031 (80 FR 3871, January As of the effective date of this AD, a MLG
26, 2015), for the MLG upper cardan P/N upper cardan having P/N 201163620 may be [FR Doc. 2015–02923 Filed 3–5–15; 4:15 pm]
201163620 for that airplane only. installed on an airplane, provided the part BILLING CODE 4910–13–P
(1) For Airbus Model A319 series life has not exceeded the applicable life limit
airplanes, pre-Airbus Modification 26644, specified in paragraphs (g)(1) through (g)(5)
excluding corporate jets post-Airbus of this AD, and is replaced with a serviceable DEPARTMENT OF HEALTH AND
Modification 28238, 28162, and 28342: The part prior to exceeding the applicable life HUMAN SERVICES
life limit is 50,590 total flight cycles. limit specified in paragraphs (g)(1) through
(2) For Airbus Model A319 series (g)(5) of this AD. Food and Drug Administration
airplanes, post-Airbus Modification 26644,
excluding corporate jets post-Airbus (k) Other FAA AD Provisions
Modification 28238, 28162, and 28342: The The following provisions also apply to this 21 CFR Part 15
life limit is 56,480 total flight cycles. AD: [Docket No. FDA–2014–N–1168]
(3) For Airbus Model A320 series airplanes (1) Alternative Methods of Compliance
pre-Airbus Modification 26644 having weight (AMOCs): The Manager, International Generic Drug User Fee Amendments of
variant (WV) WV011, WV012, WV016, or Branch, ANM–116, Transport Airplane 2012; Regulatory Science Initiatives;
WV018: The life limit is 50,590 total flight Directorate, FAA, has the authority to
cycles.
Public Hearing; Request for Comments
approve AMOCs for this AD, if requested
(4) For Airbus Model A320 series airplanes using the procedures found in 14 CFR 39.19. AGENCY: Food and Drug Administration,
post-Airbus Modification 26644, having In accordance with 14 CFR 39.19, send your HHS.
WV011, WV012, WV016, or WV018: The life request to your principal inspector or local
limit is 56,480 total flight cycles. ACTION: Notification of public hearing;
Flight Standards District Office, as
(5) For Airbus Model A320 series airplanes appropriate. If sending information directly
request for comments.
post-Airbus Modification 26644, having to the International Branch, send it to ATTN:
WV015 or WV017: The life limit is 42,140 SUMMARY: The Food and Drug
Sanjay Ralhan, Aerospace Engineer,
total flight cycles. Administration (FDA) is announcing a
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind public hearing that will provide an
(h) Additional Life Limit Clarifications
Avenue SW., Renton, WA 98057–3356; overview of the current status of
(1) The life limits specified in paragraphs regulatory science initiatives for generic
telephone 425–227–1405; fax 425–227–1149.
(g)(1) through (g)(5) of this AD are total flight drugs and an opportunity for public
cycles accumulated by the MLG since first Information may be emailed to: 9-ANM-116-
installation on an airplane. AMOC-REQUESTS@faa.gov. Before using input on research priorities in this area.
(2) The life limits specified in paragraphs any approved AMOC, notify your appropriate FDA is seeking this input from a variety
(g)(1) through (g)(5) of this AD are applicable principal inspector, or lacking a principal of stakeholders—industry, academia,
only for the airplane model, configuration inspector, the manager of the local flight patient advocates, professional societies,
and WV specified in those paragraphs. standards district office/certificate holding and other interested parties—as it
(3) If a part is transferred between airplanes district office. The AMOC approval letter
fulfills its commitment under the
having a different life limit for the MLG unit, must specifically reference this AD.
(2) Contacting the Manufacturer: For any Generic Drug User Fee Amendments of
adjust the life limit using the method 2012 (GDUFA) to develop an annual list
specified in Airbus A318/A319/A320/A321 requirement in this AD to obtain corrective
actions from a manufacturer, the action must of regulatory science initiatives specific
ALS Part 1—Safe Life Airworthiness
Limitation Items, Revision 02, dated May 13, be accomplished using a method approved to generic drugs. FDA will take the
2011, which is incorporated by reference in by the Manager, International Branch, ANM– information it obtains from the public
AD 2014–23–15, Amendment 39–18031 (80 116, Transport Airplane Directorate, FAA; or hearing into account in developing the
FR 3871, January 26, 2015). the European Aviation Safety Agency fiscal year (FY) 2016 Regulatory Science
(4) An MLG unit on which Airbus (EASA); or Airbus’s EASA Design Plan.
Modification 26644 is installed is also known Organization Approval (DOA). If approved by
the DOA, the approval must include the DATES: The public hearing will be held
as ‘‘enhanced’’ landing gear and is identified on June 5, 2015, from 9 a.m. to 5 p.m.
as P/N 201582xxx Leg and Dressing Series. DOA-authorized signature.
An MLG unit that does not have Airbus
The public hearing may be extended or
(l) Related Information may end early depending on the level of
Modification 26644 installed is identified as
P/N 201375xxx Leg and Dressing Series. (The (1) Refer to Mandatory Continuing public participation.
xxx designation is a placeholder for Airworthiness Information (MCAI) European ADDRESSES: The public hearing will be
numbers). Aviation Safety Agency Airworthiness
Directive 2014–0141, dated June 4, 2014, for
held at the FDA White Oak Campus,
(5) For airplanes with configurations not 10903 New Hampshire Ave., Bldg. 31
specified in paragraphs (g)(1) through (g)(5) related information. This MCAI may be
found in the AD docket on the Internet at Conference Center, the Great Room (Rm.
of this AD, the life limit for the MLG unit is
specified in Airbus A318/A319/A320/A321 http://www.regulations.gov by searching for 1503), Silver Spring, MD 20993–0002.
ALS Part 1—Safe Life Airworthiness and locating Docket No. FAA–2015–0244. Entrance for the public hearing
Limitation Items, Revision 02, dated May 13, (2) For service information identified in participants (non-FDA employees) is
2011, which is incorporated by reference in this AD, contact Airbus, Airworthiness through Building 1, where routine
AD 2014–23–15, Amendment 39–18031 (80 Office—EIAS, 1 Rond Point Maurice security check procedures will be
mstockstill on DSK4VPTVN1PROD with PROPOSALS
FR 3871, January 26, 2015). Bellonte, 31707 Blagnac Cedex, France; performed. For parking and security
telephone +33 5 61 93 36 96; fax +33 5 61 information, please refer to http://www.
(i) No Alternative Actions and Intervals 93 44 51; email account.airworth-eas@
airbus.com; Internet http://www.airbus.com.
fda.gov/AboutFDA/WorkingatFDA/
After the maintenance or inspection
program, as applicable, has been revised as You may view this service information at the BuildingsandFacilities/WhiteOak
required by paragraph (g) of this AD, no FAA, Transport Airplane Directorate, 1601 CampusInformation/ucm241740.htm.
alternative actions (e.g., inspections) or Lind Avenue SW., Renton, WA. For Registration and Requests for Oral
intervals may be used unless the actions or information on the availability of this Presentations: The FDA Conference
intervals are approved as an alternative material at the FAA, call 425–227–1221. Center at the White Oak location is a
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![11968 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Proposed Rules
1. Opportunities for scientific or (21 CFR 10.205), representatives of the • Hand Deliver to: Superintendent,
technical advancements that would help media may be permitted, subject to Lake Meredith National Recreation
to overcome specific barriers for certain limitations, to videotape, film, or Area, 419 E. Broadway, Fritch, TX
industry that currently limit the otherwise record FDA’s public 79036.
availability of generic drug products. administrative proceedings, including Instructions: All submissions received
2. Innovative approaches to presentations by participants. The must include the agency name and RIN
preapproval development of generic hearing will be transcribed as stipulated for this rulemaking. Comments received
drugs, including new methodologies for in § 15.30(b) (see Transcripts under will be posted without change to http://
design and conduct of in vitro, ex vivo, ADDRESSES). To the extent that the www.regulations.gov, including any
and clinical studies and identification of conditions for the hearing, as described personal information provided. For
scientifically robust strategies for in this document, conflict with any additional information, see the ‘‘Public
demonstration of bioequivalence for provisions set out in part 15, this Participation’’ heading of the
various product classes. document acts as a waiver of those SUPPLEMENTARY INFORMATION section of
3. Innovations in scientific provisions as specified in § 15.30(h). this document.
approaches to evaluating the therapeutic Docket: For access to the docket to
Dated: February 23, 2015.
equivalence of generic drug products read background documents or
through later stages of their lifecycle Leslie Kux,
comments received, go to http://
following initial approval. Associate Commissioner for Policy. www.regulations.gov.
4. Identification of high-impact public [FR Doc. 2015–05018 Filed 3–4–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
health issues involving generic drugs BILLING CODE 4164–01–P
that can be addressed by the prioritized Robert Maguire, Superintendent, Lake
allocation of FY 2016 funding for Meredith National Recreation Area,
regulatory science research. Alibates Flint Quarries National
DEPARTMENT OF THE INTERIOR Monument, P.O. Box 1460, Fritch, Texas
5. Identification of specific issues
related to generic drug products where National Park Service 79036–1460, by phone at 806–857–
scientific recommendations and/or 3151, or by email at Robert_Maguire@
clarifications are needed in developing 36 CFR Part 7 nps.gov.
and/or revising FDA’s guidance for SUPPLEMENTARY INFORMATION:
[NPS–LAMR–17097; PPWONRADE2,
industry.
6. Strategies for enhancing quality and
PMP00EI05.YP0000] Purpose and Significance of Lake
equivalence risk management during RIN 1024–AD86
Meredith National Recreation Area
generic drug product development, Congress established Lake Meredith
during regulatory review, and/or Special Regulations; Areas of the National Recreation Area (LAMR or
throughout the drug product’s lifecycle National Park System, Lake Meredith recreation area) in 1990 ‘‘to provide for
following initial approval. National Recreation Area, Off-Road public outdoor recreation use and
FDA will consider all comments made Motor Vehicles enjoyment of the lands and waters
at this hearing or received through the associated with Lake Meredith in the
AGENCY: National Park Service, Interior.
docket (see Comments under State of Texas, and to protect the scenic,
ADDRESSES) as it develops its FY 2016 ACTION: Proposed rule. scientific, cultural, and other values
GDUFA Regulatory Science Plan. SUMMARY: The National Park Service contributing to the public enjoyment of
Additional information concerning proposes to amend its special such lands and waters. . . .’’ 16 U.S.C
GDUFA, including the text of the law regulations for Lake Meredith National 460eee.
and the commitment letter, can be Situated approximately 35 miles
Recreation Area to require permits to
found at http://www.fda.gov/gdufa. operate motor vehicles off roads, north of Amarillo, Texas within Potter,
designate areas and routes where motor Moore, Hutchinson, and Carson
VI. Notice of Hearing Under 21 CFR
vehicles may be used off roads, create counties, LAMR is approximately
Part 15
management zones that would further 45,000 acres in size and is the largest
The Commissioner of Food and Drugs public landmass in the Texas
is announcing that the public hearing manage this activity, and establish
Panhandle. LAMR includes a variety of
will be held in accordance with 21 CFR camping, operational, and vehicle
habitats that are uncommon in the
part 15. The hearing will be conducted requirements. These changes would
region, including aquatic, wetland, and
by a presiding officer, who will be allow off-road vehicle use for recreation
while reducing associated impacts to riparian areas, and one of the few areas
accompanied by FDA senior in the region with trees. The natural and
management from the Office of the resources. Unless authorized by special
regulation, operating a motor vehicle off geologic resources of the area have
Commissioner and the Center for Drug enabled a continuum of human
Evaluation and Research. Under roads within areas of the National Park
System is prohibited. presence in the area for more than
§ 15.30(f) (21 CFR 15.30), the hearing is 13,000 years. The exposed geologic
informal and the rules of evidence do DATES: Comments must be received by features on the walls of the Canadian
not apply. No participant may interrupt May 4, 2015. River valley (i.e., the ‘‘breaks’’) reveal
the presentation of another participant. ADDRESSES: You may submit comments, active geologic processes that are easily
Only the presiding officer and panel identified by the Regulation Identifier
mstockstill on DSK4VPTVN1PROD with PROPOSALS
visible to an extent not present
members may pose questions; they may Number (RIN) 1024–AD86, by any of the elsewhere in the region. The recreation
question any person during or at the following methods: area is also home to the Arkansas River
conclusion of each presentation. Public • Federal eRulemaking Portal: http:// shiner (Notropis girardi), a fish species
hearings under part 15 are subject to www.regulations.gov. Follow the that is federally listed as threatened.
FDA’s policy and procedures for instructions for submitting comments.
electronic media coverage of FDA’s • Mail: Superintendent, Lake Authority To Promulgate Regulations
public administrative proceedings (21 Meredith National Recreation Area, P.O. The National Park Service (NPS)
CFR part 10, subpart C). Under § 10.205 Box 1460, Fritch, TX 79036. manages LAMR under statute
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Document Created: 2015-12-18 12:09:23
Document Modified: 2015-12-18 12:09:23
| 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 | Proposed Rules | |
| Action | Notification of public hearing; request for comments. | |
| Dates | The public hearing will be held on June 5, 2015, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. | |
| Contact | Thushi Amini, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4728, Silver Spring, MD 20993; 240-402- 7958, email: [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, email: Robert.Lionb[email protected] | |
| FR Citation | 80 FR 11966 |
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