81 FR 76361 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 212 (November 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76361-76362 | |
| FR Document | 2016-26398 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Notices] [Pages 76361-76362] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26398] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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 ------------------------------------------------------------------------------------ Total.......................................................... ............... ............... ............... ............... 626,735 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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
![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76361
Agency will review this copy, including waivers, and makes additional clarifying DATES: Fax written comments on the
the claimed confidential information, in changes. collection of information by December
its consideration of comments. The 2, 2016.
II. Significance of Guidance
second copy, which will have the ADDRESSES: To ensure that comments on
claimed confidential information This level 1 draft revised guidance is the information collection are received,
redacted/blacked out, will be available being issued consistent with FDA’s good OMB recommends that written
for public viewing and posted on http:// guidance practices regulation (21 CFR comments be faxed to the Office of
www.regulations.gov. Submit both 10.115). The draft revised guidance, Information and Regulatory Affairs,
copies to the Division of Dockets when finalized, will represent the OMB, Attn: FDA Desk Officer, FAX:
Management. If you do not wish your current thinking of FDA on ‘‘Animal 202–395–7285, or emailed to oira_
name and contact information to be Drug User Fees and Fee Waivers and submission@omb.eop.gov. All
made publicly available, you can Reductions.’’ It does not establish any comments should be identified with the
provide this information on the cover rights for any person and is not binding OMB control number 0910–0302. Also
sheet and not in the body of your on FDA or the public. You can use an include the FDA docket number found
comments and you must identify this alternative approach if it satisfies the in brackets in the heading of this
information as ‘‘confidential.’’ Any requirements of the applicable statutes document.
information marked as ‘‘confidential’’ and regulations.
FOR FURTHER INFORMATION CONTACT: FDA
will not be disclosed except in III. Paperwork Reduction Act of 1995 PRA Staff, Office of Operations, Food
accordance with 21 CFR 10.20 and other and Drug Administration, Three White
applicable disclosure law. For more This draft revised guidance refers to
previously approved collections of Flint North, 10A63, 11601 Landsdown
information about FDA’s posting of St., North Bethesda, MD 20852,
comments to public dockets, see 80 FR information that are subject to review by
the Office of Management and Budget PRAStaff@fda.hhs.gov.
56469, September 18, 2015, or access SUPPLEMENTARY INFORMATION: In
the information at: http://www.fda.gov/ (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The compliance with 44 U.S.C. 3507, FDA
regulatoryinformation/dockets/ has submitted the following proposed
default.htm. collections of information referred to in
the guidance entitled ‘‘Animal Drug collection of information to OMB for
Docket: For access to the docket to review and clearance.
read background documents or the User Fees and Fee Waivers and
electronic and written/paper comments Reductions’’ have been approved under Human Tissue Intended for
received, go to http:// OMB control number 0910–0540. Transplantation—21 CFR Part 1270
www.regulations.gov and insert the IV. Electronic Access OMB Control Number 0910–0302—
docket number, found in brackets in the Persons with access to the Internet Extension
heading of this document, into the may obtain the draft revised guidance at Under section 361 of the Public
‘‘Search’’ box and follow the prompts either http://www.fda.gov/ Health Services Act (42 U.S.C. 264),
and/or go to the Division of Dockets AnimalVeterinary/ FDA issued regulations under part 1270
Management, 5630 Fishers Lane, Rm. GuidanceComplianceEnforcement/ (21 CFR part 1270) to prevent the
1061, Rockville, MD 20852. GuidanceforIndustry/default.htm or transmission of human
Submit written requests for single
http://www.regulations.gov. immunodeficiency virus, hepatitis B,
copies of the guidance to the Policy and
Dated: October 27, 2016. and hepatitis C through the use of
Regulations Staff (HFV–6), Center for
Leslie Kux, human tissue for transplantation. The
Veterinary Medicine, Food and Drug
regulations provide for inspection by
Administration, 7519 Standish Pl., Associate Commissioner for Policy.
FDA of persons and tissue
Rockville, MD 20855. Send one self- [FR Doc. 2016–26406 Filed 11–1–16; 8:45 am]
establishments engaged in the recovery,
addressed adhesive label to assist that BILLING CODE 4164–01–P screening, testing, processing, storage,
office in processing your requests. See or distribution of human tissue. These
the SUPPLEMENTARY INFORMATION section facilities are required to meet provisions
for electronic access to the draft revised DEPARTMENT OF HEALTH AND intended to ensure appropriate
guidance document. HUMAN SERVICES screening and testing of human tissue
FOR FURTHER INFORMATION CONTACT: donors and to ensure that records are
Diane Heinz, Center for Veterinary Food and Drug Administration
kept documenting that the appropriate
Medicine (HFV–6), Food and Drug [Docket No. FDA–2013–N–0797] screening and testing have been
Administration, 7519 Standish Pl., completed.
Rockville, MD 20855, 240–402–5692, Agency Information Collection Section 1270.31(a) through (d)
diane.heinz@fda.hhs.gov. Activities; Proposed Collection; requires written procedures to be
SUPPLEMENTARY INFORMATION:
Comment Request; Human Tissue prepared and followed for the following
Intended for Transplantation steps: (1) All significant steps in the
I. Background infectious disease testing process under
AGENCY: Food and Drug Administration,
FDA is announcing the availability of HHS. § 1270.21; (2) all significant steps for
a draft revised GFI #170 entitled ACTION: Notice. obtaining, reviewing, and assessing the
‘‘Animal Drug User Fees and Fee relevant medical records of the donor as
Waivers and Reductions.’’ This draft SUMMARY: The Food and Drug prescribed in § 1270.21; (3) designating
sradovich on DSK3GMQ082PROD with NOTICES
revised guidance document describes Administration (FDA or we) is and identifying quarantined tissue; and
the types of fees FDA is authorized to announcing that a proposed collection (4) for prevention of infectious disease
collect under ADUFA and how to of information has been submitted to the contamination or cross-contamination
request waivers and reductions from Office of Management and Budget by tissue during processing. Section
these fees. It clarifies the criteria for (OMB) for review and clearance under 1270.31(a) and (b) also requires
Barrier to Innovation waivers, clarifies the Paperwork Reduction Act of 1995 recording and justification of any
the procedures for Small Business (the PRA). deviation from the written procedures.
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![76362 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
Section 1270.33(a) requires records to be information provided by industry, there 1270. Therefore, their information
maintained concurrently with the are estimated totals of 2,141,960 collection burden is for the general
performance of each significant step conventional tissue products and review and update of written
required in the performance of 130,987 eye tissue products distributed procedures estimated to take an annual
infectious disease screening and testing per year with an average of 25 percent average of 24 hours, and for the
of human tissue donors. Section of the tissue discarded due to recording and justifying of any
1270.33(f) requires records to be unsuitability for transplant. In addition, deviations from the written procedures
retained regarding the determination of there are an estimated 29,799 deceased under § 1270.31(a) and (b), estimated to
the suitability of the donors and of the donors of conventional tissue and take an annual average of 1 hour. The
records required under § 1270.21. 70,027 deceased donors of eye tissue information collection burden for
Section 1270.33(h) requires all records each year. maintaining records concurrently with
to be retained for at least 10 years Accredited members of the American the performance of each significant
beyond the date of transplantation if Association of Tissue Banks (AATB) screening and testing step and for
known, distribution, disposition, or and Eye Bank Association of America retaining records for 10 years under
expiration of the tissue, whichever is (EBAA) adhere to standards of those § 1270.33(a), (f), and (h) include
the latest. Section 1270.35(a) through (d) organizations that are comparable to the documenting the results and
requires specific records to be recordkeeping requirements in part interpretation of all required infectious
maintained to document the following: 1270. Based on information provided by disease tests and results and the identity
(1) The results and interpretation of all CBER’s database system, 90 percent of and relevant medical records of the
required infectious disease tests; (2) the conventional tissue banks are donor required under § 1270.35(a) and
information on the identity and relevant members of AATB (262 × 90% = 236), (b). Therefore, the burden under these
medical records of the donor; (3) the and 95 percent of eye tissue banks are provisions is calculated together in table
receipt and/or distribution of human members of EBAA (121 × 95% = 115). 1. The recordkeeping estimates for the
tissue, and (4) the destruction or other Therefore, recordkeeping by these 351 number of total annual records and
disposition of human tissue. establishments (236 + 115 = 351) is hours per record are based on
Respondents to this collection of excluded from the burden estimates as information provided by industry and
information are manufacturers of human usual and customary business activities FDA experience.
tissue intended for transplantation. (5 CFR 1320.3(b)(2)). The recordkeeping In the Federal Register of June 6, 2016
Based on information from the Center burden, thus, is estimated for the (81 FR 36310), we published a 60-day
for Biologics Evaluation and Research’s remaining 32 establishments, which is notice requesting public comment on
(CBER’s) database system, FDA 8.36 percent of all establishments (383 the proposed extension of this
estimates that there are approximately ¥ 351 = 32, or 32/383 = 8.36%). collection of information. No comments
383 tissue establishments, of which 262 FDA assumes that all current tissue were received.
are conventional tissue banks and 121 establishments have developed written FDA estimates the burden of this
are eye tissue banks. Based on procedures in compliance with part information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
ecordkeeper 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
Total .................................................................... .......................... .......................... .......................... .......................... 626,735
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. DEPARTMENT OF HEALTH AND forthcoming public advisory committee
Leslie Kux, HUMAN SERVICES meeting of the Science Board to the
Associate Commissioner for Policy. Food and Drug Administration. The
Food and Drug Administration Science Board provides advice to the
[FR Doc. 2016–26398 Filed 11–1–16; 8:45 am]
Commissioner of Food and Drugs and
BILLING CODE 4164–01–P [Docket No. FDA–2016–N–0001] other appropriate officials on specific,
complex scientific and technical issues
Science Board to the Food and Drug
important to FDA and its mission,
Administration Advisory Committee;
including emerging issues within the
sradovich on DSK3GMQ082PROD with NOTICES
Notice of Meeting
scientific community. Additionally, the
AGENCY: Food and Drug Administration, Science Board provides advice to the
HHS. Agency on keeping pace with technical
ACTION: Notice. and scientific developments including
in regulatory science, input into the
SUMMARY: The Food and Drug Agency’s research agenda and on
Administration (FDA) announces a upgrading its scientific and research
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Document Created: 2016-11-02 01:41:11
Document Modified: 2016-11-02 01:41:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 2, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 76361 |
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