Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation, 76361-76362 [2016-26398]

Download as PDF Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 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 guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft revised guidance document. FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5692, diane.heinz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES I. Background FDA is announcing the availability of a draft revised GFI #170 entitled ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ This draft revised guidance document describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions from these fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business VerDate Sep<11>2014 17:18 Nov 01, 2016 Jkt 241001 waivers, and makes additional clarifying changes. II. Significance of Guidance This level 1 draft revised guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft revised guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information referred to in the guidance entitled ‘‘Animal Drug User Fees and Fee Waivers and Reductions’’ have been approved under OMB control number 0910–0540. IV. Electronic Access Persons with access to the Internet may obtain the draft revised guidance at either https://www.fda.gov/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–26406 Filed 11–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0797] Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) 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 (the PRA). SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 76361 Fax written comments on the collection of information by December 2, 2016. ADDRESSES: 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 0910–0302. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. DATES: Human Tissue Intended for Transplantation—21 CFR Part 1270 OMB Control Number 0910–0302— Extension Under section 361 of the Public Health Services Act (42 U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) to prevent the transmission of human immunodeficiency virus, hepatitis B, and hepatitis C through the use of human tissue for transplantation. The regulations provide for inspection by FDA of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet provisions intended to ensure appropriate screening and testing of human tissue donors and to ensure that records are kept documenting that the appropriate screening and testing have been completed. Section 1270.31(a) through (d) requires written procedures to be prepared and followed for the following steps: (1) All significant steps in the infectious disease testing process under § 1270.21; (2) all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as prescribed in § 1270.21; (3) designating and identifying quarantined tissue; and (4) for prevention of infectious disease contamination or cross-contamination by tissue during processing. Section 1270.31(a) and (b) also requires recording and justification of any deviation from the written procedures. E:\FR\FM\02NON1.SGM 02NON1 76362 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices Section 1270.33(a) requires records to be maintained concurrently with the performance of each significant step required in the performance of infectious disease screening and testing of human tissue donors. Section 1270.33(f) requires records to be retained regarding the determination of the suitability of the donors and of the records required under § 1270.21. Section 1270.33(h) requires all records to be retained for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is the latest. Section 1270.35(a) through (d) requires specific records to be maintained to document the following: (1) The results and interpretation of all required infectious disease tests; (2) information on the identity and relevant medical records of the donor; (3) the receipt and/or distribution of human tissue, and (4) the destruction or other disposition of human tissue. Respondents to this collection of information are manufacturers of human tissue intended for transplantation. Based on information from the Center for Biologics Evaluation and Research’s (CBER’s) database system, FDA estimates that there are approximately 383 tissue establishments, of which 262 are conventional tissue banks and 121 are eye tissue banks. Based on information provided by industry, there are estimated totals of 2,141,960 conventional tissue products and 130,987 eye tissue products distributed per year with an average of 25 percent of the tissue discarded due to unsuitability for transplant. In addition, there are an estimated 29,799 deceased donors of conventional tissue and 70,027 deceased donors of eye tissue each year. Accredited members of the American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) adhere to standards of those organizations that are comparable to the recordkeeping requirements in part 1270. Based on information provided by CBER’s database system, 90 percent of the conventional tissue banks are members of AATB (262 × 90% = 236), and 95 percent of eye tissue banks are members of EBAA (121 × 95% = 115). Therefore, recordkeeping by these 351 establishments (236 + 115 = 351) is excluded from the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the remaining 32 establishments, which is 8.36 percent of all establishments (383 ¥ 351 = 32, or 32/383 = 8.36%). FDA assumes that all current tissue establishments have developed written procedures in compliance with part 1270. Therefore, their information collection burden is for the general review and update of written procedures estimated to take an annual average of 24 hours, and for the recording and justifying of any deviations from the written procedures under § 1270.31(a) and (b), estimated to take an annual average of 1 hour. The information collection burden for maintaining records concurrently with the performance of each significant screening and testing step and for retaining records for 10 years under § 1270.33(a), (f), and (h) include documenting the results and interpretation of all required infectious disease tests and results and the identity and relevant medical records of the donor required under § 1270.35(a) and (b). Therefore, the burden under these provisions is calculated together in table 1. The recordkeeping estimates for the number of total annual records and hours per record are based on information provided by industry and FDA experience. In the Federal Register of June 6, 2016 (81 FR 36310), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per ecordkeeper Average burden per recordkeeping Total annual records Total hours 1270.31(a), (b), (c), and (d) 2 ..................................... 1270.31(a) and 1270.31(b) 3 ...................................... 1270.33(a), (f), and (h), and 1270.35(a) and (b) ....... 1270.35(c) .................................................................. 1270.35(d) .................................................................. 32 32 32 32 32 1 2 6,198.84 11,876.12 1,484.50 32 64 198,363 380,036 47,504 24 1 1 1 1 768 64 198,363 380,036 47,504 Total .................................................................... .......................... .......................... .......................... .......................... 626,735 1 There are no capital costs or operating and maintenance costs associated with this collection of information. and update of standard operating procedures (SOPs). of deviations from SOPs. 2 Review 3 Documentation Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–26398 Filed 11–1–16; 8:45 am] sradovich on DSK3GMQ082PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a SUMMARY: VerDate Sep<11>2014 17:18 Nov 01, 2016 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency’s research agenda and on upgrading its scientific and research E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76361-76362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26398]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by
December 2, 2016.

ADDRESSES: 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 0910-0302.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Human Tissue Intended for Transplantation--21 CFR Part 1270

OMB Control Number 0910-0302--Extension

Under section 361 of the Public Health Services Act (42 U.S.C.
264), FDA issued regulations under part 1270 (21 CFR part 1270) to
prevent the transmission of human immunodeficiency virus, hepatitis B,
and hepatitis C through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
Section 1270.31(a) through (d) requires written procedures to be
prepared and followed for the following steps: (1) All significant
steps in the infectious disease testing process under Sec. 1270.21;
(2) all significant steps for obtaining, reviewing, and assessing the
relevant medical records of the donor as prescribed in Sec. 1270.21;
(3) designating and identifying quarantined tissue; and (4) for
prevention of infectious disease contamination or cross-contamination
by tissue during processing. Section 1270.31(a) and (b) also requires
recording and justification of any deviation from the written
procedures.

[[Page 76362]]

Section 1270.33(a) requires records to be maintained concurrently with
the performance of each significant step required in the performance of
infectious disease screening and testing of human tissue donors.
Section 1270.33(f) requires records to be retained regarding the
determination of the suitability of the donors and of the records
required under Sec. 1270.21. Section 1270.33(h) requires all records
to be retained for at least 10 years beyond the date of transplantation
if known, distribution, disposition, or expiration of the tissue,
whichever is the latest. Section 1270.35(a) through (d) requires
specific records to be maintained to document the following: (1) The
results and interpretation of all required infectious disease tests;
(2) information on the identity and relevant medical records of the
donor; (3) the receipt and/or distribution of human tissue, and (4) the
destruction or other disposition of human tissue.
Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, FDA estimates that there are approximately 383 tissue
establishments, of which 262 are conventional tissue banks and 121 are
eye tissue banks. Based on information provided by industry, there are
estimated totals of 2,141,960 conventional tissue products and 130,987
eye tissue products distributed per year with an average of 25 percent
of the tissue discarded due to unsuitability for transplant. In
addition, there are an estimated 29,799 deceased donors of conventional
tissue and 70,027 deceased donors of eye tissue each year.
Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information provided by CBER's
database system, 90 percent of the conventional tissue banks are
members of AATB (262 x 90% = 236), and 95 percent of eye tissue banks
are members of EBAA (121 x 95% = 115). Therefore, recordkeeping by
these 351 establishments (236 + 115 = 351) is excluded from the burden
estimates as usual and customary business activities (5 CFR
1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the
remaining 32 establishments, which is 8.36 percent of all
establishments (383 - 351 = 32, or 32/383 = 8.36%).
FDA assumes that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, their
information collection burden is for the general review and update of
written procedures estimated to take an annual average of 24 hours, and
for the recording and justifying of any deviations from the written
procedures under Sec. 1270.31(a) and (b), estimated to take an annual
average of 1 hour. The information collection burden for maintaining
records concurrently with the performance of each significant screening
and testing step and for retaining records for 10 years under Sec.
1270.33(a), (f), and (h) include documenting the results and
interpretation of all required infectious disease tests and results and
the identity and relevant medical records of the donor required under
Sec. 1270.35(a) and (b). Therefore, the burden under these provisions
is calculated together in table 1. The recordkeeping estimates for the
number of total annual records and hours per record are based on
information provided by industry and FDA experience.
In the Federal Register of June 6, 2016 (81 FR 36310), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received.
FDA estimates the burden of this information collection as follows:

Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) \2\.................................. 32 1 32 24 768
1270.31(a) and 1270.31(b) \3\...................................... 32 2 64 1 64
1270.33(a), (f), and (h), and 1270.35(a) and (b)................... 32 6,198.84 198,363 1 198,363
1270.35(c)......................................................... 32 11,876.12 380,036 1 380,036
1270.35(d)......................................................... 32 1,484.50 47,504 1 47,504
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Total.......................................................... ............... ............... ............... ............... 626,735
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26398 Filed 11-1-16; 8:45 am]
BILLING CODE 4164-01-P

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