Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability, 13798-13801 [2016-05718]

Download as PDF 13798 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices Application No. Drug Name Active Ingredient(s) Strength(s) Dosage Form/ Route Applicant NDA 011602 ......... KENALOG ............ 0.025%; 0.1% ..................................... Lotion; Topical ..... Delcor Asset Corp. NDA 016059 ......... INDOCIN .............. Triamcinolone Acetonide. Indomethacin ....... 25 milligrams (mg); 50 mg ................. Capsule; Oral ....... NDA 017560 ......... Sulfamethoxazole; Trimethoprim. 200 mg/5 milliliters (mL); 40 mg/5 mL Suspension; Oral Sulfamethoxazole; Trimethoprim. 200 mg/5 mL; 40 mg/5 mL ................. Suspension; Oral NDA 018185 ......... BACTRIM and BACTRIM PEDIATRIC. SEPTRA and SEPTRA GRAPE. INDOCIN SR ........ Iroko Pharmaceuticals, LLC. Mutual Pharmaceutical Company, Inc. Monarch Pharmaceuticals, Inc. Indomethacin ....... 75 mg ................................................. NDA 018450 ......... NITROPRESS ...... 50 mg/vial ........................................... Iroko Pharmaceuticals, LLC. AbbVie Inc. NDA 019834 ......... PLENDIL .............. Sodium Nitroprusside. Felodipine ............ NDA 021475 ......... METHYLIN ........... NDA 050320 ......... UNIPEN ................ Methylphenidate Hydrochloride. Nafcillin Sodium ... Extended-Release Capsule; Oral. Injectable; Injection. Extended-Release Tablet; Oral. Chewable Tablet; Oral. Injectable; Injection. NDA 050406 ......... KEFLEX ............... Cephalexin ........... Shionogi Inc. ANDA 060576 ...... MYCOLOG–II ....... Delcor Asset Corp. ANDA 062117 ...... CEPHALEXIN ...... Nystatin; Triamcinolone Acetonide. Cephalexin ........... For Suspension; Oral. Cream; Topical ..... ANDA 062606 ...... MYCOLOG–II ....... EQ 125 mg base/5 mL; EQ 250 mg base/5 mL; EQ 100 mg base/mL. 100,000 units/g; 0.1% ........................ For suspension; Oral. Cream; Topical ..... Facta Farmaceutici S.p.A. Delcor Asset Corp. ANDA 062717 ...... UNIPEN ............... EQ 500 mg base/vial; EQ 1 g base/ vial; EQ 2 g base/vial. Injectable; Injection. Wyeth Ayerst Pharmaceuticals. asabaliauskas on DSK3SPTVN1PROD with NOTICES NDA 017598 ......... Nystatin; Triamcinolone Acetonide. Nafcillin Sodium ... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 2.5 mg; 5 mg; 10 mg .......................... 2.5 mg; 5 mg; 10 mg .......................... Equal to (EQ) 500 mg base/vial; EQ 1 g (gram) base/vial; EQ 2 g base/ vial; EQ 4 g base/vial; EQ 10 g base/vial; EQ 20 g base/vial. EQ 125 mg base/5 mL; EQ 250 mg base/5 mL; EQ 100 mg base/mL. 100,000 units/g; 0.1% ........................ Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05717 Filed 3–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1814] Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 AstraZeneca. Mallinckrodt Pharmaceuticals. Wyeth Ayerst Pharmaceuticals. Draft Guidance for Industry.’’ The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of pathogen reduction technology (PRT) or bacterial testing. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The draft guidance replaces the draft guidance entitled ‘‘Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,’’ dated December 2014. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ‘‘Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods’’ dated December 2007. E:\FR\FM\15MRN1.SGM 15MRN1 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 13, 2016. Submit either electronic or written comments on the collection of information by May 16, 2016. ADDRESSES: You may submit comments as follows: DATES: asabaliauskas on DSK3SPTVN1PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/ paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–D–1814 for ‘‘Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 13799 SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Information Collection Requirements: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. Guidance Document: Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.’’ Platelets are associated with a higher risk of sepsis and are related to more fatalities than any other transfusable blood component. The risk of bacterial contamination of platelets is a leading risk of infection from blood transfusion. This risk has persisted despite numerous interventions including the introduction, in the last decade, of analytically sensitive culturebased bacterial detection methods, which are widely used to test platelets prior to their release from blood collection establishments to transfusion services. The draft guidance provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of PRT or bacterial testing. PRT is performed shortly after platelet collection by blood collection establishments. Bacterial testing encompasses primary testing of platelets by blood collection establishments and subsequent secondary testing prior to transfusion primarily by transfusion services. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. Additionally, the draft guidance provides recommendations to licensed blood establishments for submitting biologics license application supplements to E:\FR\FM\15MRN1.SGM 15MRN1 13800 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices include bacterial testing of platelet components. The guidance informs transfusion services that are currently exempt from registration and blood product listing that if they choose to perform secondary testing of platelets to extend the dating period, they must register with FDA and list the blood products they manufacture. The draft guidance applies to all platelet products, including platelets manufactured from Whole Blood (Whole Blood Derived (WBD) platelets), platelets collected by automated methods from a single donor (apheresis platelets), pooled platelets, and platelets stored in additive solutions. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 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 submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. 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. Title: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. Description: We have identified the following recommendations in the draft guidance document as collections of information. In section VI, the draft guidance recommends that blood collection establishments have in place measures to promptly alert the transfusion services in the event that a distributed platelet product is subsequently identified as positive for bacterial contamination. In section X.A.2, the draft guidance recommends that following secondary testing, labeling on the container label or a tietag, should relay the following information: (1) Type of bacterial detection test performed (rapid or culture) and (2) the date and time the bacterial detection test was performed. Description of Respondents: The third-party disclosure recommendations described in the draft guidance affect blood collection establishments and transfusion services that collect and manufacture platelet products for transfusion, including WBD platelets, apheresis platelets, pooled platelets, and platelets stored in additive solutions. Burden Estimate: The Agency believes the information collection provision for blood collection establishments in section VI does not create a new burden for respondents and is part of usual and customary business practice. Blood collection establishments currently have in place standard operating procedures for notifying consignees (transfusion services) if a distributed platelet product has subsequently tested positive for bacterial contamination. In section X.A.2, the draft guidance recommends that following secondary testing, establishments should maintain a labeling process that relays certain information and is integral to the container (e.g., on the container label or an attached tie-tag) and label accordingly. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Section X.A.2: Following secondary testing, maintain a labeling process that relays certain information and is integral to the container (e.g., on the container label or an attached tie-tag) and label accordingly. 2480 403 1,000,000 .05 (3 minutes) .... 50,000 asabaliauskas on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 1 provides an estimate of the annual third-party disclosure burden for the information to be submitted in accordance with the draft guidance. Based on FDA data and information submitted by industry, FDA believes that there are approximately 2 million platelet transfusions per year. The recommendation for labeling following secondary testing applies to approximately 4,960 transfusion VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 services in the Unites States. We estimate that about 50 percent of all platelets will be pathogen-reduced and 50 percent will be cultured. Therefore, to estimate the annual third-party disclosure burden in table 1, we assume that approximately one-half of the transfusion services will label one-half of the total platelets intended for transfusion in the United States following secondary testing. The PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 average burden disclosure for transfusion services to implement the recommendation in table 1 is based on FDA’s experience and industry information. This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 601.12 and 610.60 have been approved under OMB control number E:\FR\FM\15MRN1.SGM 15MRN1 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 0910–0338; the collections of information in 21 CFR 606.65, 606.100, 606.120, 606.121, 606.122, and have been approved under OMB control number 0910–0116; and the collections of information in 21 CFR part 607 have been approved under OMB control number 0910–0052. To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB (see ADDRESSES). All comments should be identified with the title of the information collection. In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this document to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3815] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing Food and Drug Administration, HHS. asabaliauskas on DSK3SPTVN1PROD with NOTICES ACTION: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0625. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Electronic Submission of Medical Device Registration and Listing—21 CFR Part 807, Subparts A Through D; OMB Control Number 0910–0625— Extension [FR Doc. 2016–05718 Filed 3–14–16; 8:45 am] AGENCY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 14, 2016. SUMMARY: Notice. Under section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners and operators are required to electronically submit establishment registration and device listing information. Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: (1) Identification of establishments producing marketed medical devices, (2) identification of establishments producing a specific device when that 13801 device is in short supply or is needed for national emergency, (3) facilitation of recalls for devices marketed by owners and operators of device establishments, (4) identification and cataloguing of marketed devices, (5) administering postmarketing surveillance programs for devices, (6) identification of devices marketed in violation of the law, (7) identification and control of devices imported into the country from foreign establishments, (8) and scheduling and planning inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374). Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices, who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements. The number of respondents is based on data from the FDA Unified Registration and Listing System. Burden estimates are based on recent experience with the existing medical device registration and listing program, electronic system operating experience, and the economic analysis for the final rule entitled ‘‘Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007.’’ In the Federal Register of October 27, 2015 (80 FR 65779), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Section FDA Form No. 807.20(a)(5) 2—Submittal of manufacturer information by initial importers. 807.20(a)(5) 3—Submittal of manufacturer information by initial importers. VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 Number of respondents Number of responses per respondent Average burden per response Total annual responses Total hours 3673 1 8,594 1.75 ................ 15,040 3673 PO 00000 8,594 8,594 3 25,782 .1 .................... (6 minutes) ..... 2,578 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13798-13801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05718]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1814]


Bacterial Risk Control Strategies for Blood Collection 
Establishments and Transfusion Services To Enhance the Safety and 
Availability of Platelets for Transfusion; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Bacterial Risk Control 
Strategies for Blood Collection Establishments and Transfusion Services 
to Enhance the Safety and Availability of Platelets for Transfusion; 
Draft Guidance for Industry.'' The draft guidance document provides 
blood collection establishments and transfusion services with 
recommendations to control the risk of bacterial contamination of room 
temperature stored platelets intended for transfusion through the 
implementation of pathogen reduction technology (PRT) or bacterial 
testing. The draft guidance also provides recommendations for the use 
of secondary testing of platelets as the basis to extend the dating 
period of platelets, when appropriately labeled bacterial detection 
devices and storage containers are used. The draft guidance replaces 
the draft guidance entitled ``Bacterial Detection Testing by Blood 
Collection Establishments and Transfusion Services to Enhance the 
Safety and Availability of Platelets for Transfusion,'' dated December 
2014. The draft guidance, when finalized, is intended to supersede the 
recommendation in section VII.A.2, in regard to bacterial contamination 
testing in the document entitled ``Guidance for Industry and FDA Review 
Staff: Collection of Platelets by Automated Methods'' dated December 
2007.

[[Page 13799]]


DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 13, 2016. Submit either electronic or written comments 
on the collection of information by May 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1814 for ``Bacterial Risk Control Strategies for Blood 
Collection Establishments and Transfusion Services to Enhance the 
Safety and Availability of Platelets for Transfusion; Draft Guidance 
for Industry.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 240-402-8010. See 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Information Collection Requirements: 
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
PRAStaff@fda.hhs.gov.
    Guidance Document: Jonathan McKnight, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Bacterial Risk Control Strategies for Blood Collection Establishments 
and Transfusion Services to Enhance the Safety and Availability of 
Platelets for Transfusion; Draft Guidance for Industry.'' Platelets are 
associated with a higher risk of sepsis and are related to more 
fatalities than any other transfusable blood component. The risk of 
bacterial contamination of platelets is a leading risk of infection 
from blood transfusion. This risk has persisted despite numerous 
interventions including the introduction, in the last decade, of 
analytically sensitive culture-based bacterial detection methods, which 
are widely used to test platelets prior to their release from blood 
collection establishments to transfusion services.
    The draft guidance provides blood collection establishments and 
transfusion services with recommendations to control the risk of 
bacterial contamination of room temperature stored platelets intended 
for transfusion through the implementation of PRT or bacterial testing. 
PRT is performed shortly after platelet collection by blood collection 
establishments. Bacterial testing encompasses primary testing of 
platelets by blood collection establishments and subsequent secondary 
testing prior to transfusion primarily by transfusion services. The 
draft guidance also provides recommendations for the use of secondary 
testing of platelets as the basis to extend the dating period of 
platelets, when appropriately labeled bacterial detection devices and 
storage containers are used. Additionally, the draft guidance provides 
recommendations to licensed blood establishments for submitting 
biologics license application supplements to

[[Page 13800]]

include bacterial testing of platelet components. The guidance informs 
transfusion services that are currently exempt from registration and 
blood product listing that if they choose to perform secondary testing 
of platelets to extend the dating period, they must register with FDA 
and list the blood products they manufacture.
    The draft guidance applies to all platelet products, including 
platelets manufactured from Whole Blood (Whole Blood Derived (WBD) 
platelets), platelets collected by automated methods from a single 
donor (apheresis platelets), pooled platelets, and platelets stored in 
additive solutions.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on bacterial risk 
control strategies for blood collection establishments and transfusion 
services to enhance the safety and availability of platelets for 
transfusion. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    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 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    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.
    Title: Bacterial Risk Control Strategies for Blood Collection 
Establishments and Transfusion Services to Enhance the Safety and 
Availability of Platelets for Transfusion.
    Description: We have identified the following recommendations in 
the draft guidance document as collections of information. In section 
VI, the draft guidance recommends that blood collection establishments 
have in place measures to promptly alert the transfusion services in 
the event that a distributed platelet product is subsequently 
identified as positive for bacterial contamination. In section X.A.2, 
the draft guidance recommends that following secondary testing, 
labeling on the container label or a tie-tag, should relay the 
following information: (1) Type of bacterial detection test performed 
(rapid or culture) and (2) the date and time the bacterial detection 
test was performed.
    Description of Respondents: The third-party disclosure 
recommendations described in the draft guidance affect blood collection 
establishments and transfusion services that collect and manufacture 
platelet products for transfusion, including WBD platelets, apheresis 
platelets, pooled platelets, and platelets stored in additive 
solutions.
    Burden Estimate: The Agency believes the information collection 
provision for blood collection establishments in section VI does not 
create a new burden for respondents and is part of usual and customary 
business practice. Blood collection establishments currently have in 
place standard operating procedures for notifying consignees 
(transfusion services) if a distributed platelet product has 
subsequently tested positive for bacterial contamination.
    In section X.A.2, the draft guidance recommends that following 
secondary testing, establishments should maintain a labeling process 
that relays certain information and is integral to the container (e.g., 
on the container label or an attached tie-tag) and label accordingly. 
FDA estimates the burden of this collection of information as follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                    Activity                         Number of     disclosures per    Total annual     Average burden  per disclosure      Total hours
                                                    respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section X.A.2: Following secondary testing,                 2480              403        1,000,000   .05 (3 minutes)...................          50,000
 maintain a labeling process that relays certain
 information and is integral to the container
 (e.g., on the container label or an attached
 tie-tag) and label accordingly.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 provides an estimate of the annual third-party disclosure 
burden for the information to be submitted in accordance with the draft 
guidance. Based on FDA data and information submitted by industry, FDA 
believes that there are approximately 2 million platelet transfusions 
per year. The recommendation for labeling following secondary testing 
applies to approximately 4,960 transfusion services in the Unites 
States. We estimate that about 50 percent of all platelets will be 
pathogen-reduced and 50 percent will be cultured. Therefore, to 
estimate the annual third-party disclosure burden in table 1, we assume 
that approximately one-half of the transfusion services will label one-
half of the total platelets intended for transfusion in the United 
States following secondary testing. The average burden disclosure for 
transfusion services to implement the recommendation in table 1 is 
based on FDA's experience and industry information.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR 601.12 and 610.60 have been approved under OMB control number

[[Page 13801]]

0910-0338; the collections of information in 21 CFR 606.65, 606.100, 
606.120, 606.121, 606.122, and have been approved under OMB control 
number 0910-0116; and the collections of information in 21 CFR part 607 
have been approved under OMB control number 0910-0052.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this document to OMB 
for review. These requirements will not be effective until FDA obtains 
OMB approval. FDA will publish a notice concerning OMB approval of 
these requirements in the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05718 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.