Source: https://www.federalregister.gov/documents/2018/05/11/2018-10052/agency-information-collection-activities-proposed-collection-comment-request-request-for-samples-and
Timestamp: 2019-08-23 06:30:27
Document Index: 461502393

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Submit either electronic or written comments on the collection of information by July 10, 2018.
Docket No. FDA-2018-N-1565
FDA-2018-N-1565
OMB Control Number 0910-0206—Extension
https://www.federalregister.gov/d/2018-10052 https://www.federalregister.gov/d/2018-10052
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the Agency.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 10, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Instructions: All submissions received must include the Docket No. FDA-2018-N-1565 for “Request for Samples Start Printed Page 22082and Protocols.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Under section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to issue regulations that prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that the biologics licenses for such products are only issued when a product meets the prescribed standards. Under § 610.2 (21 CFR 610.2), the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of applicable tests prior to distributing the lot of the product. In addition to § 610.2, there are other regulations that require the submission of samples and protocols for specific licensed biological products: 21 CFR 660.6 (Antibody to Hepatitis B Surface Antigen); 21 CFR 660.36 (Reagent Red Blood Cells); 21 CFR 660.46) (Hepatitis B Surface Antigen).
Section 660.6(a) provides requirements for the frequency of submission of samples from each lot of Antibody to Hepatitis B Surface Antigen product, and § 660.6(b) provides the requirements for the submission of a protocol containing specific information along with each required sample. For § 660.6 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history of manufacture of the product, including all results of each test for which test results are requested by CBER. After official release is no longer required, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary.
Section 660.46(a) contains requirements as to the frequency of submission of samples from each lot of Hepatitis B Surface Antigen product, and § 660.46(b) contains the requirements as to the submission of a protocol containing specific information along with each required sample. For § 660.46 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history or manufacture of the product, including all results of each test for which test results are requested by CBER. After notification of official release is received, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary.
Samples and protocols are required by FDA to help ensure the safety, purity, or potency of the product because of the potential lot-to-lot variability of a Start Printed Page 22083product produced from living organisms. In cases of certain biological products (e.g., Albumin, Plasma Protein Fraction, and therapeutic biological products) that are known to have lot-to-lot consistency, official lot release is not normally required. However, submissions of samples and protocols of these products may still be required for surveillance, licensing, and export purposes, or in the event that FDA obtains information that the manufacturing process may not result in consistent quality of the product.
The following burden estimate is for the protocols required to be submitted with each sample. The collection of samples is not a collection of information under 5 CFR 1320.3(h)(2). Respondents to the collection of information under § 610.2 are manufacturers of licensed biological products. Respondents to the collection of information under §§ 660.6(b), 660.36(a)(2) and (b), and 660.46(b) are manufacturers of the specific products referenced previously in this document. The estimated number of respondents for each regulation is based on the annual number of manufacturers that submitted samples and protocols for biological products including submissions for lot release, surveillance, licensing, or export. Based on information obtained from FDA's database system, approximately 79 manufacturers submitted samples and protocols in fiscal year (FY) 2017, under the regulations cited previously in this document. FDA estimates that approximately 75 manufacturers submitted protocols under § 610.2 and two manufacturers submitted protocols under the regulation (§ 660.6) for the other specific product. FDA received no submissions under §§ 660.36 or 660.46, however FDA is using the estimate of one protocol submission under each regulation in the event that protocols are submitted in the future.
The estimated total annual responses are based on FDA's final actions completed in FY 2017 for the various submission requirements of samples and protocols for the licensed biological products. The average burden per response is based on information provided by industry. The burden estimates provided by industry ranged from 1 to 5.5 hours. Under § 610.2, the hours per response are based on the average of these estimates and rounded to 3 hours. Under the remaining regulations, the average burden per response is based on the higher end of the estimate (rounded to 5 or 6 hours) since more information is generally required to be submitted in the other protocols than under § 610.2. FDA estimates the burden of this information collection as follows:
610.2—Requests for Samples and Protocols; Official Release 75 86.267 6,470 3 19,410
660.6(b)—Protocols 2 3.5 7 5 35
660.36(a)(2) and (b)—Samples and Protocols 1 1 1 6 6
660.46(b)—Protocols 1 1 1 5 5
Total 79 6,479 19,456
Our estimated burden for the information collection reflects an overall increase of 764 hours and a corresponding increase of 262 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.
[FR Doc. 2018-10052 Filed 5-10-18; 8:45 am]