This information collection requires
recordkeeping from establishments that collect blood and blood
components and transfusion services to establish and maintain
procedures and records for donors and the collection, processing,
testing, storage, and distribution of blood and blood components.
This information also requires notification to certain blood
collection establishments concerning bacterial contamination of
platelets. The information collection required by these regulations
would be used by the collecting establishment to help ensure that a
donor of blood and blood components is free of infectious disease,
in good health, and eligible to donate without adversely affecting
the health of the donor. In addition, the information collection
would be used by the collecting establishment to determine that
donations are suitable for transfusion or further
manufacture.
US Code:
42
USC 262 Name of Law: Public Health Service Act
US Code: 42
USC 264 Name of Law: Public Health Service Act
US Code: 21
USC 321 Name of Law: Federal Food, Drug, and Cosmetic Act
Statute at Large: 21 Stat. 606 Name of
Statute: null
Statute at Large: 21 Stat. 630 Name of Statute: null
Statute at Large: 21 Stat. 640 Name of Statute: null
Ila Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
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.