67 FR 149 pgs. 50445-50447 - Agency Information Collection Activities; Proposed Collection;Comment Request; Blood Establishment Registration and Product Listing, FormFDA 2830
Type: NOTICEVolume: 67Number: 149Pages: 50445 - 50447
Docket number: [Docket No. 02n-0319]
FR document: [FR Doc. 02-19493 Filed 8-1-02; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02n-0319]
Agency Information Collection Activities; Proposed Collection;Comment Request; Blood Establishment Registration and Product Listing, FormFDA 2830
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing an opportunity for public comment on the proposed collection ofcertain information by the agency. Under the Paperwork Reduction Act of1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection ofinformation, including each proposed extension of an existing collection ofinformation, and to allow 60 days for public comment in response to thenotice. This notice solicits comments on the information collectionprovisions relating to the blood establishment registration and productlisting requirements and Form FDA 2830.
DATES:
Submit written or electronic comments on thecollection of information by October 1, 2002.
ADDRESSES:
Submit written comments on the collection ofinformation to the Dockets Management Branch (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submitelectronic comments on the collection of information to http://www.accessdata.fda.gov/scripts/ oc/dockets/edockethome.cfm . Allcomments should be identified with the docket number found in brackets inthe heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn P.Capezzuto, Office of Information Resources Management (HFA-250), Foodand Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtainapproval from the Office of Management and Budget (OMB) for each collectionof information they conduct or sponsor. "Collection ofinformation" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) andincludes agency requests or requirements that members of the public submitreports, keep records, or provide information to a third party. Section3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federalagencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposedextension of an existing collection of information, before submitting thecollection to OMB for approval. To comply with this requirement, FDA ispublishing notice of the proposed collection of information set forth inthis document.
With respect to the following collection of information, FDA invitescomments on: (1) Whether the proposed collection of information isnecessary for the proper performance of FDA's functions, including whetherthe information will have practical utility; (2) the accuracy of FDA'sestimate of the burden of the proposed collection of information, includingthe validity of the methodology and assumptions used; (3) ways to enhancethe quality, utility, and clarity of the information to be collected; and(4) ways to minimize the burden of the collection of information onrespondents, including through the use of automated collection techniqueswhen appropriate, and other forms of information technology.
Blood Establishment Registration and Product Listing, Form FDA2830-21 CFR Part 607-(OMB Control Number0910-0052)-Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.360), any person owning or operating an establishment that manufactures,prepares, propagates, compounds, or processes a drug or device mustregister with the Secretary of Health and Human Services, on or beforeDecember 31 of each year, his or her name, place of business and all suchestablishments, and submit, among other information, a listing of all drugor device products manufactured, prepared, propagated, compounded, orprocessed by him or her for commercial distribution. In part 607 (21 CFRpart 607), FDA has issued regulations implementing these requirements formanufacturers of human blood and blood products.
Section 607.20(a) requires certain establishments that engage in themanufacture of blood products to register and to submit a list of bloodproducts in commercial distribution. Section 607.21 requires theestablishments entering into the manufacturing of blood products toregister within 5 days after beginning such operation and to submit a bloodproduct listing at that time. In addition, establishments are required toregister annually between November 15 and December 31 and update theirblood product listing every June and December. Section 607.22 requires theuse of Form FDA 2830 for registration and blood product listing. Section607.25 indicates the information required for establishment registrationand blood product listing. Section 607.26 requires certain changes to besubmitted as an amendment to the establishment registration within 5 daysof such changes. Section 607.30 requires establishments to update, asneeded, their blood product listing information every June and at theannual registration. Section 607.31 requires that additional blood productlisting information be provided upon FDA request. Section 607.40 requiresforeign blood product establishments to register and submit the bloodproduct listing information, the name and address of the establishment, andthe name of the individual responsible for submitting blood product listinginformation.
Among other uses, this information assists FDA in its inspections offacilities, and its collection is essential to the overall regulatoryscheme designed to ensure the safety of the nation's blood supply. FormFDA 2830, Blood Establishment Registration and Product Listing, is used tocollect this information. The likely respondents are blood banks, bloodcollection facilities, and blood component manufacturing facilities.
FDA estimates the burden of this collection of information based uponthe database and past experience of the Center for Biologics Evaluation andResearch, Division of Blood Applications in regulatory blood establishmentregistration and product listing. Most blood banks are familiar with theregulations and registration requirements to fill out this form.
| 21 CFR -Section | Form FDA 2830 | No. of -Respondents | Annual -Frequency per -Response | Total Annual -Responses | Hours per -Response | Total Hours |
|---|---|---|---|---|---|---|
| 607.20(a), 607.21, 607.22, 607.25, and 607.40 | Initial Registration | 300 | 1 | 300 | 1 | 300 |
| 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40 | Re-registration | 2,867 | 1 | 2,867 | 0.5 | 1,434 |
| 607.21, 607.25, 607.30, 607.31, and 607.40 | Product Listing -Update | 75 | 1 | 75 | 0.25 | 19 |
| Total | 1,753 | |||||
| 1 There are no capital costs or operating and maintenancecosts associated with this collection of information. | ||||||
Dated: July 26, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-19493 Filed 8-1-02; 8:45 am]
BILLING CODE 4160-01-S