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)