Call for Participation for Computational Photography Project for Pill Identification (C3PI), 56381-56382 [2014-22308]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56381-56382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22308]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Call for Participation for Computational Photography Project for 
Pill Identification (C3PI)

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Library of Medicine (NLM) invites pharmaceutical 
manufacturers, re-packagers, wholesalers, and retail and institutional 
pharmacies to submit prescription drug products for imaging as part of 
its Computational Photography Project for Pill Identification (C3PI). 
The NLM is developing the C3PI oral solid dosage formulations (OSDFs) 
collection as part of an initiative to build a reliable and high-
quality image catalog of all OSDF prescription products marketed in the 
United States. Such a resource can support a number of public safety 
initiatives, such as in poison control, emergency response, and 
reduction of medication errors.

FOR FURTHER INFORMATION CONTACT: Any question regarding this process or 
the Computational Photography Project for Pill Identification (C3PI) 
should be sent to: splimage@nlm.nih.gov.

SUPPLEMENTARY INFORMATION: The Computational Photography Project for 
Pill Identification (C3PI) aims to develop information infrastructure 
and computational tools for identifying pills from digital photographs 
and associated data. As part of C3PI, the NLM has imaged and currently 
hosts a growing collection of more than 2,000 validated images of 
pharmaceutical OSDFs. High quality images of these products, 
photographed using visible spectrum macrophotography techniques, are 
available for public access through an Applications Programming 
Interface (API) [https://RxImage.nlm.nih.gov/]. These images are also 
displayed in several NLM drug applications, including RxNav [https://rxnav.nlm.nih.gov/] and Pillbox [https://pillbox.nlm.nih.gov/].
    NLM assisted the FDA in the development the current SPLIMAGE file 
specification [https://dailymed.nlm.nih.gov/dailymed/splimagesspec.cfm], 
which was published in 2012 for submitting image files of oral solid 
dosage forms to the Food and Drug Administration (FDA) with Structured 
Product Label (SPL) documents. As part of the ongoing initiative to 
improve access to quality drug information, the NLM has worked closely 
with FDA's Center for Drug Evaluation and Research and Office of the 
Commissioner to increase the number of SPLIMAGE files included in SPL 
submissions. C3PI has successfully produced more than 2,000 SPLIMAGE 
files and these SPLIMAGE files have been made available through an NLM 
portal: https://SPLimage.nlm.nih.gov.
    NLM is seeking the collaboration of pharmaceutical manufacturers, 
re-

[[Page 56382]]

packagers, wholesalers and pharmacies to obtain physical samples of 
OSDF products whose origin can be traced back to pharmaceutical 
manufacturers or private label distributors registered or listed with 
the Food and Drug Administration (FDA). The NLM will produce SPLIMAGE 
files suitable for inclusion in submissions to the Food and Drug 
Administrations' Structured Product Labeling (SPL) program [https://www.fda.gov/forindustry/datastandards/structuredproductlabeling/default.htm]. A secure online portal will be used to make SPLIMAGE 
files available to participants responding to this Federal Register 
notice.
    C3PI will also support computer vision research. NLM computer 
scientists are seeking object identification metrics and methods that 
are invariant with respect to camera angle, lighting, and the color 
transfer functions often found in digital cameras. The comprehensive 
collection of images will serve as foundation for research in content-
based information retrieval and image-based search in an area of 
healthcare that directly impacts public safety: Safe medication 
identification and management. In addition to image data, C3PI is 
generating information on color classification, image segmentation, 
pill description and dimensions, as well as other metadata.
    C3PI is led and managed by NLM's Office of High Performance 
Computing and Communications in the Lister Hill National Center for 
Biomedical Communications. Additional information on NLM's Office of 
High Performance Computing and Communications is available at: https://lhncbc.nlm.nih.gov/branch/office-high-performance-computing-and-communications. Information on the Lister Hill National Center for 
Biomedical Communications is available at: https://lhncbc.nlm.nih.gov/.

General Instructions for Participating in C3PI

    To participate in C3PI please visit https://SPLimage.nlm.nih.gov and 
follow the specific instructions provided. General instructions follow 
below:
    1. Pharmaceutical manufacturers, private label distributors, re-
packagers, wholesalers, and retail or institutional pharmacies 
(Participants) interested in submitting OSDF products to be imaged as 
part of the NLM sponsored C3PI OSDF Imaging initiative must first 
communicate their intention to participate in the project by contacting 
the NLM Point-of-Contact (NLM-PoC) using one of the following means:

Email: splimage@nlm.nih.gov
Or mail to: The National Library of Medicine, C3PI Imaging Initiative, 
Building 38A, Room B1N-30, 8600 Rockville Pike, Bethesda, MD 20894.

    2. NLM-PoC will acknowledge the Participant's communication of 
intent and will provide the Participant with the necessary DEA and 
State Licensing documents to allow for the secure shipment of OSDF 
products to the NLM imaging facility.
    3. Prior to shipping OSDFs to the NLM imaging facility, the 
Participant will provide the NLM-PoC a detailed and complete list of 
prescription drug products that they intend to submit to NLM for 
processing and imaging.
    4. After the NLM-PoC has authorized the shipment of the 
prescription drug products in writing, the products will be sent to the 
address provided by the NLM-PoC. In order for NLM to accept the 
shipment, the participant must provide NLM-PoC with written 
confirmation for the shipment, including: (a) Shipping manifest 
details, (b) shipping service used, (c) tracking number, and (d) 
expected date of arrival.
    5. NLM will have a licensed pharmacist review the received contents 
and match them against the shipment manifest provided the NLM-PoC. NLM-
PoC will acknowledge receipt of shipment within 72hrs of its arrival at 
the appropriate location and will provide the Participant with an 
estimate of the date by which OSDF SPLIMAGE-candidate files will become 
available through the secure online portal: https://SPLimage.nlm.nih.gov.

Previous NLM Imaging Initiative Superseded

    This notice supersedes all prior instructions provided by 76 FR 
29773-29775 https://federalregister.gov/a/2011-12629, published on May 
23, 2011.

    Dated: September 12, 2014.
Betsy L. Humphreys,
Deputy Director, National Library of Medicine, National Institutes of 
Health.
[FR Doc. 2014-22308 Filed 9-18-14; 8:45 am]
BILLING CODE 4140-01-P