Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation, 72895-72897 [2013-28989]

Download as PDF Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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. FOR FURTHER INFORMATION CONTACT: Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act— (OMB Control Number 0910–0375)— Extension Section 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this thirdparty review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer’s 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer’s documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. 72895 This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices. Respondents to this information collection are businesses or other forprofit organizations. In the Federal Register of July 9, 2013 (78 FR 41065), FDA published a 60-day notice requesting public comment on the proposed collection of information to which one comment was received but was unrelated to the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of responses per respondent Number of respondents Activity Requests for Accreditation ..................... 510(k) Reviews Conducted by Accredited Third Parties ................................ Total annual responses Average burden per response 1 1 1 24 24 10 26 260 40 10,400 Total ................................................ 1 There Total hours 10,424 are no capital costs or operating and maintenance costs associated with this collection of information. 510(k) Reviews Conducted by Accredited Third Parties According to FDA’s data, the number of 510(k)s submitted for third-party review is approximately 260 annually, which is 26 annual reviews per each of the 10 accredited reviewers. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 510(k) reviews ........................................ 10 26 260 10 2,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Third-party reviewers are required to keep records of their review of each submission. According to FDA’s data, the Agency anticipates approximately 260 submissions of 510(k)s for thirdparty review per year. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 27, 2013. Leslie Kux, Assistant Commissioner for Policy. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation EMCDONALD on DSK67QTVN1PROD with NOTICES [FR Doc. 2013–29010 Filed 12–3–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2013–N–0797] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 3, 2014. 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. FDA PRA Staff, Office of Operations, Food FOR FURTHER INFORMATION CONTACT: E:\FR\FM\04DEN1.SGM 04DEN1 72896 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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 (PHS) 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 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) 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. 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 281 tissue establishments of which 185 are conventional tissue banks and 96 are eye tissue banks. Based on information provided by industry, there are an estimated total of 1,959,270 conventional tissue products and 82,741 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 30,380 donors of conventional tissue and 49,026 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 (185 × 90 percent = 166), and 85 percent of eye tissue banks are members of EBAA (96 × 85 percent = 82). Therefore, recordkeeping by these 248 establishments (166 + 82 = 248) 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 33 establishments, which is 12 percent of all establishments (281¥248 = 33, or 33 ÷ 281 = 12 percent). 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 of this document. 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 July 10, 2013 (78 FR 41403), FDA published a 60-day notice requesting public comment on the proposed collection of information. One letter of comment was received from a trade organization. The comment requested that the notice be corrected to reflect that an estimated total of 1,959,270 conventional tissue products are distributed (not recovered) per year. The comment also requested a revision in the number of donors of conventional tissues based on the AATB Annual Survey 2007. FDA agrees with these comments and made the recommended changes. FDA estimates the burden of this information collection as follows: EMCDONALD on DSK67QTVN1PROD with NOTICES TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Part 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) ............................................................................ VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00038 Number of records per recordkeeper 33 33 33 33 33 Fmt 4703 Sfmt 4703 1 2 7,714.24 14,850.96 1,856.36 Total annual records Average burden per recordkeeping 33 66 254,570 490,082 61,260 24 1 1 1 1 E:\FR\FM\04DEN1.SGM 04DEN1 Total hours 792 66 254,570 490,082 61,260 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices 72897 TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR Part Number of records per recordkeeper Total annual records Total .............................................................................. Average burden per recordkeeping Total hours 806,770 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: November 27, 2013. Leslie Kux, Assistant Commissioner for Policy. SUMMARY: Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Drug Registration and Listing Team, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3100. SUPPLEMENTARY INFORMATION: 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 a draft guidance describing the updated format for long-term use, submit either electronic or written comments on this draft guidance by February 3, 2014. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by February 3, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ The draft guidance is being issued to implement new provisions added to the FD&C Act in the DQSA. In the newly enacted legislation, Congress created a new statutory category of ‘‘outsourcing facilities’’ that compound drugs. New section 503B of the FD&C Act (21 U.S.C. 353b) allows compounders to register with FDA as outsourcing facilities and, among other things, imposes reporting requirements on these entities if they choose to register. The draft guidance is intended to assist registered outsourcing facilities in implementing drug reporting. The draft guidance describes how an outsourcing facility should provide interim electronic reports while FDA modifies its existing electronic drug registration and listing system to accommodate reporting of product information by registered outsourcing facilities under section 503B of the FD&C Act. When the Agency has modified its current electronic submission system to allow outsourcing [FR Doc. 2013–28989 Filed 12–3–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1428] Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA), and sets forth an interim electronic submission method for human drug compounders that choose to register as outsourcing facilities (outsourcing facilities). EMCDONALD on DSK67QTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 facilities to submit information electronically through a Structured Product Labeling file, FDA intends to issue a draft guidance describing the updated format for long-term use. When such guidance is issued in final form, it will specify the form of reporting that outsourcing facilities are to follow from that point forward. The draft guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. Elsewhere in this issue of the Federal Register, the Agency is making available for comment a draft guidance on registration for human drug compounding outsourcing facilities under section 503B of the FD&C Act. II. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995 (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 that 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 for 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 collection of information associated with this document, FDA invites comments on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72895-72897]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Human Tissue Intended 
for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: 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 January 
3, 2014.

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

[[Page 72896]]

and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 
20850, 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 (PHS) 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 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) 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. 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 281 tissue 
establishments of which 185 are conventional tissue banks and 96 are 
eye tissue banks. Based on information provided by industry, there are 
an estimated total of 1,959,270 conventional tissue products and 82,741 
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 30,380 donors of conventional tissue 
and 49,026 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 (185 x 90 percent = 166), and 85 percent of eye tissue 
banks are members of EBAA (96 x 85 percent = 82). Therefore, 
recordkeeping by these 248 establishments (166 + 82 = 248) 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 33 establishments, which is 12 percent of all establishments 
(281-248 = 33, or 33 / 281 = 12 percent).
    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 of this document. 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 July 10, 2013 (78 FR 41403), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One letter of comment was received from a 
trade organization. The comment requested that the notice be corrected 
to reflect that an estimated total of 1,959,270 conventional tissue 
products are distributed (not recovered) per year. The comment also 
requested a revision in the number of donors of conventional tissues 
based on the AATB Annual Survey 2007. FDA agrees with these comments 
and made the recommended changes.
    FDA estimates the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
           21 CFR Part                Number of     records per    Total annual         per         Total hours
                                    recordkeepers   recordkeeper      records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) \2\              33           1                 33              24             792
1270.31(a) and 1270.31(b) \3\....              33           2                 66               1              66
1270.33(a), (f), and (h), and                  33       7,714.24         254,570               1         254,570
 1270.35(a) and (b)..............
1270.35(c).......................              33      14,850.96         490,082               1         490,082
1270.35(d).......................              33       1,856.36          61,260               1          61,260
                                  ------------------------------------------------------------------------------

[[Page 72897]]

 
    Total........................                                                                        806,770
----------------------------------------------------------------------------------------------------------------
\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: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28989 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P

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