The primary purpose of FDA's Adverse Experience Reporting (AER) system is to identify potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. AER reports are obtained from a variety of sources, including manufacturers, patients, physicians, foreign regulatory agencies, and clinical investigators. Identification of new and unexpected safety issues through the analysis of the data in the AERS system contributes directly to increased public health protection.
The semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, the fill lot numbers for the total number of dosage units of each strength or potency distributed ( e.g., 50,000 per 10-milliliter vials), and date of release. This allows FDA to estimate more accurately the incidence of a product's adverse effects in relation to the volume of the product distributed.
The recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also provide FDA with the necessary information to help ensure the safety, purity, and potency of biological products and enable FDA to perform meaningful inspections. Without this information, FDA could not monitor industry procedures and discharge its statutory responsibility for protecting the nation's health.
The estimated total annual burden for this information collection in 2010 was 2,096,444 hours. The current increase to the total annual burden of 4,293,381 burden hours is mostly attributed to the increase in the number of respondents and total annual responses (number of AER reports) submitted under 21 CFR 600.80(c)(2) and the corresponding recordkeeping requirements under 21 CFR 600.80(i). The increase under these requirements (~ 2,200,000) is due to the normal variation in the submission of AER reports depending on various factors (e.g., new biological products on the market).
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 3500A 600.80(c)(1) and 600.80(e)
SUPPORTING STATEMENT FINAL 11-3-14.docx
600.80(c)(1) and 600.80(e)