[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41266-41267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17515]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0012]


Critical Path Manufacturing Sector Research Initiative (U01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of a cooperative agreement 
with the National Institute for Pharmaceutical Technology and Education 
Initiative (NIPTE).
    Development of the Critical Path Manufacturing Sector Initiative 
has focused attention on the continuing need for this kind of research 
in a way that can improve reliability of pharmaceutical product 
manufacturing and quality across the entire industry. This shared 
knowledge will increase the likelihood of successfully manufacturing 
products that have been identified in the clinical development 
community. The goal of this agreement is to improve the overall 
manufacturing and quality and the knowledge base.

DATES: Important dates are as follows:
    1. The application due date is July 20, 2011.
    2. The anticipated start date is August 31, 2011.
    3. The opening date is July 13, 2011.
    4. The expiration date is July 22, 2011.
    For Further Information and Additional Requirements Contact:
    For Programmatic and Scientific Questions and Concerns contact:
    Jon Clark, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4178, Silver 
Spring, MD 20993, 301-796-2400; E-mail: [email protected].
    For Administrative and Financial Questions and Concerns contact: 
Gladys Melendez, Office of Acquisitions and Grant Support, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1078, Rockville, MD 20857, 
301-827-7175; E-mail: [email protected].
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm under the ``Regulatory Information'' section. The title 
of the page is ``Research Acquisitions.''

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

    Funding Opportunity Number: RFA-FD-11-014.
    Catalog of Federal Domestic Assistance: 93.103.

A. Background

    The Office of Pharmaceutical Science has conducted research within 
the academic community through contracts in order to improve the 
overall manufacturing and quality knowledge base. This research is 
important to the public sector, because research conducted in 
pharmaceutical sciences related to product quality is typically kept 
proprietary.
    Development of the Critical Path Manufacturing Sector Initiative 
has focused attention on the continuing need for this kind of research 
in a way that can improve reliability of pharmaceutical product 
manufacturing and quality across the entire industry. This shared 
knowledge will increase the likelihood of successful manufacturing.

B. Research Objectives

    The grant will support programs and research as described in the 
following paragraphs, related to the manufacturing of drugs, biological 
products, and medical devices:
     Education and training in the field of manufacturing and 
scale-up, for product development partnerships, academic scientists, 
other product developers and product application reviewers.
     Development of platform strategies and standardized 
approaches for medical product manufacturing to shorten timelines for 
manufacturers to produce quality medical products at commercial scale. 
This will provide publicly available models for manufacturing and 
scale-up that will help enable small firms to expeditiously market 
important treatments.
     Development of analytical methodologies and advanced 
computational methodologies to better characterize complex molecules 
and complex mixtures of molecules is needed to better understand and 
control manufacturing processes and product quality. Specific 
analytical techniques will better enable standardized approaches to 
manufacturing control and advance computational technologies will help 
to identify atypical samples of complex molecules. These advances will 
help assure pharmaceutical quality for the American public.
     Research into improved techniques for collection and 
analysis of process data to control processes and to ensure that they 
are in statistical control will be done. This includes science-based 
flexible and adaptive approaches to manufacturing utilizing feed 
forward and feed backward information flow. Standardized approaches to 
assuring product quality using manufacturing and analytical data will 
support continued product quality and lessen manufacturing failures 
thus decreasing shortages of medically necessary products.
     Development of techniques for assuring product quality 
using surrogates for desired clinical results will improve 
understanding of quality target product profile. This approach takes 
advantage of the potential to use existing clinical data to determine 
clinically relevant specifications including unit-to-unit variability, 
drug dissolution, and other material or product attributes, and to 
support future manufacturing improvements while maintaining product 
quality.
     Creating simulation models for manufacturing techniques 
including but not limited to biotech fermentation and cell culture, 
small molecule crystallization, freeze drying techniques, and precision 
tablet coating will enhance industry knowledge. These models will 
enable a more predictable approach to manufacturing development and 
design of control systems. This predictability will shorten the 
critical path pipeline from laboratory to clinic and support continual 
improvement to achieve product quality of the drug's lifecycle.
     Creating simulation models for complex drug delivery 
devices such as dry product inhalers, transdermal patches, and 
liposomal products to better understand the product design and 
performance and to control the critical manufacturing parameters. These 
models will aid to speed the development of novel dosage forms and 
decrease the failure rates of these products.
     Research into product formulation for special patient 
populations or product formulation to ensure chemical stability of 
active ingredients will shorten formulation development and

[[Page 41267]]

thus, the critical path pipeline. This research does not require 
clinical or animal studies. Instead, it will lead to the creation of 
materials with physical properties in materials that have been 
previously identified as being desirable.
     Physical characteristics of active ingredients and 
recipients in drug products, such as crystal morphology, co-crystal 
technology, dispersions, and particle sizing including nanotechnology 
are not fully developed in the public sector. This work will develop 
technology enabling control of these attributes. This will provide 
another dimension of control to the predictability of pharmaceutical 
products. This added control will enable new approaches to 
manufacturing novel dosage forms and shorten the time it takes to 
develop manufacturing processes and controls.
     Development of specialized manufacturing techniques 
suitable for products administered in low dosages and for products with 
high toxicity or narrow therapeutic ranges. This will enable more rapid 
development of manufacturing techniques for these products.
     Development of models for manufacturing and engineering of 
device products such as infusion pumps, prosthetic organs, 
defibrillators, tissue engineering devices, and combination products 
will help standardize the approach for bringing these medical products 
to market. This includes development of components for more reliable 
delivery of pharmaceuticals to the most desirable site of action, for 
example, controlling the air plume of inhaled products. This will 
shorten the time required to move such products from concept to patient 
and thereby shorten the Industrialization sector of the Critical Path.
     Research into methods for laboratory synthesis of 
molecules that have been designed by computer simulation will shorten 
medical product development time. These methods will make the creation 
of these molecules more predictable. These technologies will also 
enable new drug discoveries to be brought to market faster with less 
variability; higher predictability of performance.
     Approaches to improve facilities where this research will 
be conducted. Advanced technology development can be accelerated by 
better design of the facilities where this research is conducted. 
Creating and making these designs public will have the effect of 
accelerating technology across the industry. This will shorten the time 
it takes to bring these advanced technologies into the product 
manufacturing sector.

C. Eligibility Information

    National Institute for Pharmaceutical Technology and Education 
Initiative (NIPTE), a Nonprofit Other Than Institutions of Higher 
Education, described in section 501(c)(3) of the Internal Revenue Code 
of 1986 (26 U.S.C. 501(c)(3), which is exempt from tax under section 
501(a) of that code.
    NIPTE is the only consortium of universities of its kind. The 
organization consists of many of the most highly qualified 
pharmaceutical manufacturing experts in academia. Research conducted by 
NIPTE Faculty is collaborative by design to provide for coordinated 
publication of the cutting-edge research results.
    An eligible organization that wishes to enter into a collaborative 
agreement must provide an assurance that the entity will not accept 
funding for a Critical Path Public-Private Partnership Project from any 
organization that manufactures or distributes products regulated by FDA 
unless the entity provides assurance in its agreement with FDA that the 
results of the Critical Path Public Partnership project will not be 
influenced by any source of funding. The entities eligible to enter 
into partnerships with FDA are governed by section 566 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb5).
    This cooperative agreement will provide continued support for 
established and previously funded collaborations on behalf of FDA 
priorities.

II. Award Information/Funds Available

A. Award Amount

    Only one grant will be awarded. In fiscal year 2011, there is 
currently $700,000 available. As funds are available, partner 
components may supplement up to $7,000,000 total cost per year, 
depending on the availability of fiscal year funds.

B. Length of Support

    Application budgets are not limited, but need to reflect actual 
needs of the proposed project. This Cooperative Agreement is capable of 
awarding a total of $35,000,000 over the entire award project period 
depending upon progress, the need for, and the availability of fiscal 
year funds.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement located at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm located under 
the ``Regulatory Information'' section. The title of the page is 
``Research Acquisitions.''
    Persons interested in applying for a grant may obtain an 
application at http://grants.nih.gov/grants/forms.htm. For all paper 
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
     Step 3: Register With Electronic Research Administration 
(eRA) Commons.
    Steps 1 and 2, in detail, can be found at: http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to Gladys Melendez, Grants Management 
Officer/Grants Management Specialist (see For Further Information and 
Additional Requirements Contact).

    Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17515 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P