Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of two related draft guidance documents. One is a draft guidance entitled, ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Notification [510(k)] Submissions'' (``CADe 510(k) draft guidance''). This draft guidance provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The second draft guidance is entitled, ``Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Approval (PMA) and Premarket Notification [510(k)] Submissions'' (``CADe clinical performance assessment draft guidance''). This draft guidance provides recommendations on how to design and conduct clinical performance studies for CADe devices applied to radiology images and radiology device data. These studies may be part of a premarket submission to FDA, whether it is a 510(k) submission, an application for premarket approval (PMA), an application for a humanitarian device exemption (HDE), or an application for an investigational device exemption (IDE). These draft guidances are not final nor are they in effect at this time.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,'' dated October 2009. In this draft guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This draft guidance provides advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor- investigators) to assist in the submission of an IND for certain HPC- Cs, when such HPC-Cs are not licensed in accordance with certain FDA regulations, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. This draft guidance document is applicable only to HPC-Cs intended for hematopoietic reconstitution in patients with the clinical indications listed in the guidance entitled ``Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' (HPC-C licensure guidance), published elsewhere in this issue of the Federal Register. FDA is also announcing that it no longer intends to exercise enforcement discretion with respect to the IND and biologics license application (BLA) requirements for minimally manipulated, unrelated allogeneic hematopoietic stem/progenitor cell products and the phase-in implementation period for IND and license application requirements will end as of October 20, 2011.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The CERHR announces the availability of the draft expert panel report on soy formula on October 19, 2009, on the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on chapters 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on December 16-18, 2009, at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314 (Tel: 1-703-837-0440) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to soy formula is a hazard to human development. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the final report on its Web site and solicit public comment on it through a Federal Register notice.

The Food and Drug Administration (FDA) is reopening until October 19, 2010, the comment period for the notice of public meeting published in the Federal Register of April 20, 2009 (74 FR 17967). In that notice, FDA announced a public meeting that took place on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening the comment period in light of continued public interest in this topic and to provide an opportunity for all interested parties to provide information and share views on the matter.

The National Institute of Environmental Health Sciences of the National Institutes of Health is requesting nominations for members to serve on the Interagency Breast Cancer and Environmental Research Coordinating Committee. This Committee will coordinate information on existing activities related to breast cancer and environmental research and make recommendations to the National Institutes of Health and other Federal agencies on how to improve existing research programs.

The Food and Drug Administration (FDA) is classifying the wound dressing with pDADMAC additive into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive,'' which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Food and Drug Administration (FDA) is postponing the meeting of the National Mammography Quality Assurance Advisory Committee scheduled for November 2, 2009. This meeting was announced in the Federal Register of October 1, 2009 (74 FR 50803). The postponement is due to guidance documents planned for discussion at the meeting are not yet available. A future meeting date will be announced in the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of tulathromycin injectable solution for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 16, 2009, page 34580 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.