Daily Rules, Proposed Rules, and Notices of the Federal Government
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Mammography Quality Standards Act requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. The intent of these regulations is to assure safe, reliable, and accurate mammography on a nationwide level.
Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body. This requires undergoing a review of their clinical images and providing the accreditation body with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.
FDA estimates the burden of this collection of information as follows:
The following sections of title 21 of the Code of Federal Regulations (CFR) were not included in the previously mentioned burden tables because they were considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. Therefore, they resulted in no additional reporting or recordkeeping burden: 21 CFR 900.12(c)(1) and (c)(3) and 21 CFR 900.3(f)(1).
Section 900.3(c) was not included in the previously mentioned burden tables because all four existing accreditation bodies are approved until late in 2013; so, no applicants will reapply during the requested information collection period. Section 900.24(c) was also not included in the previously mentioned burden tables because if a certifying state had its approval withdrawn, FDA would take over certifying authority for the affected facilities. Because FDA already has all the certifying state's electronic records, there wouldn't be an additional reporting burden.