81 FR 66039 - A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 186 (September 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 186 (September 26, 2016)
| Page Range | 66039-66040 | |
| FR Document | 2016-23106 |
[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)] [Notices] [Pages 66039-66040] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23106] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2610] A List of Biomarkers Used as Outcomes in Development of FDA- Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration is correcting a notice entitled ``A List of Biomarkers Used as Outcomes in Development of FDA- Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket'' that appeared in the Federal Register of September 19, 2016 (81 FR 64177). The document announced the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. The document was published without an active Web link. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring MD 20993-0002, 301-796-9115, [email protected]. [[Page 66040]] SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, September 19, 2016, in FR Doc. 2016-22470, on page 64178 the following correction is made: On page 64178, in the second column, in the last sentence of the first paragraph under Section I, Background, ``Biomarkers Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007 to December 2015)'' is corrected to read ``http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm483052.htm''. Dated: September 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23106 Filed 9-23-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices 66039
of how GDUFA program resources are GDUFA II fee structure, CMOs will pay accessible at www.fda.gov/gdufa and in
used. This is described in section VI(B). one-third the annual fee paid by firms this docket at http://
The Agency would also expand its that manufacture under ANDAs which www.regulations.gov.
performance reporting by publishing they or their affiliates own. It may be viewed at the Division of
robust monthly, quarterly and annual The full descriptions of these Dockets Management, Food and Drug
program performance metrics, as proposed recommendations will be Administration, 5630 Fishers Lane, Rm.
described in section VI(C). Enhanced posted prior to the public meeting on 1061, Rockville, MD. A transcript will
performance reporting would enable FDA’s Web site at www.fda.gov/gdufa. also be available in either hardcopy or
Congress, the regulated industry, patient on CD–ROM, after submission of a
IV. Purpose and Scope of the Meeting
and consumer groups, and other Freedom of Information request. The
stakeholders to better gauge the generic If you wish to attend this meeting, Freedom of Information office address is
drug program’s performance. please email your registration available on the Agency’s Web site at
information to Derek Griffing (see FOR http://www.fda.gov.
G. Enhancements to Fee Structure and FURTHER INFORMATION CONTACT) by
Related Mechanisms To Provide Small October 7, 2016. Your email should Dated: September 21, 2016.
Business Relief and Increase contain complete contact information Leslie Kux,
Predictability, Stability, and Efficiency for each attendee, including name, title, Associate Commissioner for Policy.
The proposed GDUFA II fee structure affiliation, address, email address, and [FR Doc. 2016–23111 Filed 9–23–16; 8:45 am]
was designed to provide FDA with telephone number. Registration is free BILLING CODE 4164–01–P
predictable, adequate funding for its and is on a first-come, first-served basis.
human generic drug review programs, However, FDA may limit the number of
divide fee responsibilities equitably participants from each organization DEPARTMENT OF HEALTH AND
across different segments of the based on space limitations. Registrants HUMAN SERVICES
industry, and provide for small business will receive confirmation once they
considerations in a number of ways. have been accepted. Onsite registration Food and Drug Administration
GDUFA II will be funded at a level on the day of the meeting will be based
commensurate with the amount of work on space availability. If you need special [Docket No. FDA–2016–N–2610]
associated with incoming ANDAs, since accommodations because of a disability,
ANDAs are the primary workload driver please contact Derek Griffing (see FOR A List of Biomarkers Used as
of GDUFA. In order to provide a more FURTHER INFORMATION CONTACT) at least 7 Outcomes in Development of FDA-
predictable revenue base, GDUFA II will days before the meeting. Approved New Molecular Entities and
include an annualized ‘‘program fee’’ for The meeting will include a New Biological Therapeutics (October
ANDA holders. This annual fee will presentation by FDA and a series of 2007 to December 2015);
help offset the fluctuations in invited panels representing different Establishment of a Public Docket;
application fees from 1 year to another. stakeholder groups identified in the Correction
An ANDA sponsor will pay a fee based statute (such as patient advocacy
on the total number of approved ANDAs AGENCY: Food and Drug Administration,
groups, consumer advocacy groups,
that it and its affiliates own. ANDA HHS.
health professionals, and regulated
sponsors will be split into three tiers industry). We will also provide an ACTION: Notice; correction.
based on ANDA ownership. The opportunity for other organizations and
proposed tier cutoffs were determined SUMMARY: The Food and Drug
individuals to make presentations at the
by industry and are meant to reflect a Administration is correcting a notice
meeting or to submit written comments
firm’s size, position in the market, and entitled ‘‘A List of Biomarkers Used as
to the docket before the meeting.
reliance on the program. With the If you wish to present at the meeting, Outcomes in Development of FDA-
introduction of the program fee, FDA please include your presentation Approved New Molecular Entities and
has eliminated the fee for PASs. materials along with your registration New Biological Therapeutics (October
In addition to program fees based on information to Derek Griffing (see FOR 2007 to December 2015); Establishment
total ANDA ownership, the proposed FURTHER INFORMATION CONTACT) by
of a Public Docket’’ that appeared in the
fee structure includes two other distinct October 7, 2016. Early requests for oral Federal Register of September 19, 2016
considerations for small businesses. presentations are recommended due to (81 FR 64177). The document
First, under GDUFA I, a facility would possible space and time limitations. announced the establishment of a
pay an annual fee if it was listed in an FDA will accommodate as many docket to receive suggestions,
ANDA, regardless of whether it was requests for oral presentations as recommendations, and comments from
listed in any approved ANDAs. As a possible and will do so on a first-come, interested parties (such as academic
result, a facility that is listed only in first-served basis. The time allotted for researchers, regulated industries,
pending applications is charged an presentations may depend on the consortia, and patient groups) on a list
annual GDUFA fee even though it has number of persons who wish to speak. of biomarkers that were used as
no generic drug revenue stream. Under Those requesting to present will receive outcomes to develop FDA-approved
GDUFA II, no facility or ANDA sponsor confirmation once they have been new molecular entities (NMEs) and New
would be charged an annual fee until an accepted. Onsite requests for oral Biological Therapeutics from October
ANDA in which it is listed is approved. presentations on the day of the meeting 2007 to December 2015. The document
Second, the proposed structure adds a was published without an active Web
mstockstill on DSK3G9T082PROD with NOTICES
will be based on time and space
facility category for contract availability. If the entire meeting time is link. This document corrects that error.
manufacturing organizations (CMOs). not needed, FDA may end the public FOR FURTHER INFORMATION CONTACT: Lisa
CMOs are generally small businesses meeting early. Granger, Food and Drug Administration,
that are hired by ANDA sponsors to 10903 New Hampshire Ave., Bldg. 32,
manufacture their generic drugs. V. Transcript Request Rm. 3330, Silver Spring MD 20993–
Alternatively, some ANDA sponsors Please be advised that as soon as a 0002, 301–796–9115, lisa.granger@
manufacture their own drugs. Under the transcript is available, it will be fda.hhs.gov.
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![66040 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices
SUPPLEMENTARY INFORMATION: In the the Maternal and Child Health Bureau to Zika virus during pregnancy.
Federal Register of Monday, September (MCHB), and HRSA. The supplement Discussions of developmental screening,
19, 2016, in FR Doc. 2016–22470, on will permit the American Academy of clinical management, and family
page 64178 the following correction is Pediatrics (AAP), the cooperative support approaches will help clinicians
made: agreement awardee, during the budget serving this population, thereby
On page 64178, in the second column, period of July 1, 2016–June 30, 2017, to increasing access to well-coordinated,
in the last sentence of the first enhance their capacity to provide family-centered care and management
paragraph under Section I, Background, technical assistance and health in a medical home for children and
‘‘Biomarkers Used as Outcomes in professional education to increase the families impacted by Zika-related
Development of FDA-Approved clinical expertise of pediatric health complications.
Therapeutics (October 2007 to care professionals, including safety net The purpose of the NCMHI
December 2015)’’ is corrected to read providers, to more effectively serve as cooperative agreement is to support a
‘‘http://www.fda.gov/Drugs/ the medical home and provide family- national resource and assistance effort
DevelopmentApprovalProcess/Drug centered, comprehensive, coordinated, to implement and spread the medical
DevelopmentToolsQualification and culturally-effective care for Zika- home model to all children and youth,
Program/ucm483052.htm’’. affected children and their families. particularly CSHCN, children who are
Dated: September 21, 2016. FOR FURTHER INFORMATION CONTACT: vulnerable and/or medically
Leslie Kux, Marie Y. Mann, MD, MPH, FAAP, underserved, and pediatric populations
Associate Commissioner for Policy. Division of Services for Children with served by state public health programs,
[FR Doc. 2016–23106 Filed 9–23–16; 8:45 am]
Special Health Needs, Maternal and MCHB, and HRSA. In 2013, following
Child Health Bureau, Health Resources objective review of its competitive
BILLING CODE 4164–01–P
and Services Administration, 5600 application, HRSA awarded the NCMHI
Fishers Lane, Room 18W61, Rockville, cooperative agreement to AAP, a
DEPARTMENT OF HEALTH AND Maryland 20857; MMann@hrsa.gov. nonprofit, tax-exempt organization
HUMAN SERVICES SUPPLEMENTARY INFORMATION: under Internal Revenue Code 501(c)(3).
Intended Recipient of the Award: The This supplement to the NCMHI
Health Resources and Services American Academy of Pediatrics. cooperative agreement provides
Administration Amount of Non-Competitive Awards: technical assistance and education,
$350,000. including tele-mentoring, to clinicians
Supplement for Zika Response, a Period of Supplemental Funding: providing care for children who are or
Single-Award Deviation From 7/1/2016–6/30/2017. may be impacted by Zika at HRSA-
Competition Requirements for the CFDA Number: 93.110. supported health centers and elsewhere
National Center for Medical Home Authority: Social Security Act, Title V, within the United States (including U.S.
Implementation Cooperative sections 501(a)(1)(D) and 501(a)(2), (42 U.S.C. territories and jurisdictions). Using the
Agreement 701(a)(1)(D) and 701(a)(2)) tele-mentoring technology, clinicians
AGENCY: Health Resources and Services Justification: Zika virus infection will team with specialists elsewhere to
Administration (HRSA), Department of during pregnancy dramatically increases provide clinicians with the tools and
Health and Human Services (HHS). the risk of birth defects. Microcephaly resources to improve care delivery
ACTION: Notice. has been linked to Zika virus infection within the medical home, thereby
during pregnancy, and the extent of increasing the sustainability of the
SUMMARY: HRSA announces the award other possible birth defects is unclear. medical home model for children
of a supplement in the amount of As of August 25, 2016, there are 624 affected by Zika. Though available to all
$350,000 for the National Center for pregnant women in the 50 states and the clinicians, technical assistance and
Medical Home Implementation District of Columbia reported to have education will be directed primarily
(NCMHI) cooperative agreement. The the Zika virus infection. In Puerto Rico, toward pediatric primary care
purpose of the NCMHI cooperative over 600 pregnant women have been physicians in areas at high-risk for Zika
agreement is to support a national reported to have the Zika virus infection and toward clinicians operating in
resource and assistance effort to as a result of exposure to the Zika virus health centers supported by HRSA’s
implement and spread the medical during pregnancy. However, pediatric Bureau of Primary Health Care. These
home model to all children and youth, specialty expertise to care for their activities will provide critical
particularly children with special health babies is limited. Currently, no network knowledge to health care professionals,
care needs (CSHCN), children who are exists to link providers caring for these including safety net providers, to more
vulnerable and/or medically patients with those who have relevant effectively serve as the medical home
underserved, and pediatric populations expertise or experience in managing for children affected by Zika and their
served by state public health programs, infants and children of women exposed families.
FY 2016
FY 2016 estimated
Grantee/organization name Grant No. State authorized funding for this
funding level supplement
mstockstill on DSK3G9T082PROD with NOTICES
The American Academy of Pediatrics ............................................................. U43MC09134 IL $1,300,031 $350,000
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Document Created: 2018-02-09 13:22:29
Document Modified: 2018-02-09 13:22:29
| 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; correction. | |
| Contact | Lisa Granger, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring MD 20993-0002, 301-796-9115, [email protected] | |
| FR Citation | 81 FR 66039 |
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