Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs, 17215-17217 [2013-06351]

Download as PDF Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices Living) has submitted the following proposed collection of information to OMB for review and clearance. The ‘‘Empowering Older Adults and Adults with Disabilities through Chronic Disease Self-Management Education (CDSME) Programs’’ cooperative agreement program is financed through 2012 Prevention and Public Health Funds. The proposed data collection is necessary for monitoring grant program operations and outcomes. AoA proposes to gather information to monitor grantee progress, record location of sites where workshops are held which will allow mapping of the delivery infrastructure, and document participant attendance and demographic and health characteristics. The proposed Participant Survey requests the participants’ gender, zip code and birthdate to allow for potential Medicare claims matching and an analysis of changes in health care utilization post participation. In response to the 60-day Federal Register notice related to this proposed data collection and published on July 23, 2013, four sets of comments were received. Concern was expressed about the collection of sensitive personal information. Most of the remaining comments provided suggestions for enhancing the quality and clarity of the information to be collected. The comments resulted in some revisions to the proposed data collection tools. The originally proposed data collection tools, the comments with responses and a revised set of data collection tools may be found on the AoA Web site at: http://www.aoa.gov/AoARoot/ AoA_Programs/Tools_Resources/ collection_tools.aspx. ACL estimates the burden of this collection of information as 440 hours for State Governments, 1050 hours for local agency staff, and 2,500 hours for individuals—Total burden is 3,990 hours per year. Dated: March 15, 2013. Kathy Greenlee, Administrator and Assistant Secretary for Aging. [FR Doc. 2013–06390 Filed 3–19–13; 8:45 am] srobinson on DSK4SPTVN1PROD with NOTICES BILLING CODE 4154–01–P VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0242] Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA’s regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. DATES: Submit either electronic or written comments on the collection of information by May 20, 2013. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150– 400B, Rockville, MD 20850, 301–796– 7726, Ila.mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 17215 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, including each proposed extension of an existing 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. Current Good Manufacturing Practice for Positron Emission Tomography Drugs—(OMB Control Number 0910– 0667)—Extension Positron emission tomography is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product. FDA’s CGMP regulations at 21 CFR part 212 are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding safety, identity, strength, quality, and purity. The CGMP requirements for PET drugs are issued under the provisions of the Food and Drug Administration Modernization Act (FDAMA). These CGMP requirements are designed to take into account the unique characteristics of PET drugs, including their short halflives and the fact that most PET drugs are produced at locations that are very close to the patients to whom the drugs are administered. The CGMP regulations are intended to ensure that approved PET drugs meet the requirements of the FD&C Act as to safety, identity, strength, quality, and purity. The regulations address the following matters: Personnel and resources; quality assurance; facilities and equipment; control of components, in-process materials, and finished products; production and process controls; laboratory controls; acceptance E:\FR\FM\20MRN1.SGM 20MRN1 17216 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices criteria; labeling and packaging controls; distribution controls; complaint handling; and recordkeeping. The CGMP regulations establish several recordkeeping requirements and a third-party disclosure requirement for the production of PET drugs. In making our estimates of the time spent in complying with these information collection requirements, we relied on communications we have had with PET producers, visits by our staff to PET facilities, and our familiarity with both PET and general pharmaceutical manufacturing practices. The estimated annual recordkeeping and third-party disclosure burden is based on there being approximately 129 PET drug production facilities. Table 1 provides an estimate of the annual recordkeeping burdens. Table 2 provides an estimate of the annual third-party disclosure burdens associated with this collection. A. Investigational and Research PET Drugs Section 212.5(b)(2) provides that for investigational PET drugs produced under an investigational new drug (IND) and research PET drugs produced with approval of a Radioactive Drug Research Committee (RDRC), the requirement under the FD&C Act to follow current good manufacturing practice is met by complying with the regulations in part 212 or with USP 32 Chapter 823. We believe that PET production facilities producing drugs under INDs and RDRCs are currently substantially complying with the recordkeeping requirements of USP 32 Chapter 823 (see section 121(b) of the FDAMA), and accordingly, we do not estimate any recordkeeping burden for this provision. srobinson on DSK4SPTVN1PROD with NOTICES B. Batch Production and Control Records Sections 212.20(c) through (e), 212.50(a) through (c), and 212.80(c) set forth requirements for batch and production records as well as written control records. We estimate that it would take approximately 20 hours annually for each PET production facility to prepare and maintain written production and control procedures and to create and maintain master batch records for each PET drug produced. We also estimate that there will be a total of approximately 221 PET drugs produced, with a total recordkeeping burden of approximately 4,420 hours. We estimate that it would take a PET production facility an average of 30 minutes to complete a batch record for each of approximately 501 batches. Our estimated burden for completing batch records is approximately 32,315 hours. VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 C. Equipment and Facilities Records Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain requirements for records dealing with equipment and physical facilities. We estimate that it would take approximately 1 hour to establish and maintain these records for each piece of equipment in each PET production facility. We estimate that the total burden for establishing procedures for these records would be approximately 1,935 hours. We estimate that recording maintenance and cleaning information would take approximately 5 minutes a day for each piece of equipment, with a total recordkeeping burden of approximately 40,237 hours. test results is approximately 10,728 hours. G. Sterility Test Failure Notices Section 212.70(e) requires PET drug producers to notify all receiving facilities if a batch fails sterility tests. We believe that sterility test failures might occur in only 0.05 percent of the batches of PET drugs produced each year. Therefore, we have estimated in Table 2 that each PET drug producer will need to provide approximately 0.25 sterility test failure notice per year to receiving facilities. The notice would be provided using email or facsimile transmission and should take no more than 1 hour. D. Records of Components, Containers, and Closures Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements on records regarding receiving and testing of components, containers, and closures. We estimate that the annual burden for establishing these records would be approximately 259 hours. We estimate that each facility would receive approximately 36 shipments annually and would spend approximately 10 minutes per shipment entering records. The annual burden for maintaining these records would be approximately 771 hours. E. Process Verification Section 212.50(f)(2) requires that any process verification activities and results be recorded. Because process verification is only required when results of the production of an entire batch are not fully verified through finished-product testing, we believe that process verification will be a very rare occurrence, and we do not estimate any recordkeeping burden for documenting process verification. F. Laboratory Testing Records Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b), and 212.70(a), (b), and (d) set out requirements for documenting laboratory testing and specifications referred to in laboratory testing, including final release testing and stability testing. Each PET drug production facility will need to establish procedures and create forms for the different tests for each product they produce. We estimate that it will take each facility an average of 1 hour to establish procedures and create forms for one test. The estimated annual burden for establishing procedures and creating forms for these records is approximately 3,225 hours, and the annual burden for recording laboratory PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 H. Conditional Final Releases Section 212.70(f) requires PET drug producers to document any conditional final releases of a product. We believe that conditional final releases will be fairly uncommon, but for purposes of the PRA, we estimated that each PET production facility would have one conditional final release a year and would spend approximately 1 hour documenting the release and notifying receiving facilities. The estimate of one conditional final release per year per facility is an appropriate average number because many facilities may have no conditional final releases while others might have only a few. I. Out-of-Specification Investigations Sections 212.20(c) and 212.71(a) and (b) require PET drug producers to establish procedures for investigating products that do not conform to specifications and conduct these investigations as needed. We estimate that it will take approximately 1 hour annually to record and update these procedures for each PET production facility. We also estimate, for purposes of the PRA, that 36 out-of-specification investigations would be conducted at each facility each year and that it would take approximately 1 hour to document the investigation, which results in an annual burden of 4,644 hours. J. Reprocessing Procedures Sections 212.20(c) and 212.71(d) require PET drug producers to establish and document procedures for reprocessing PET drugs. We estimate that it will take approximately 1 hour a year to document these procedures for each PET production facility. We do not estimate a separate burden for recording the actual reprocessing, both because we believe it would be an uncommon event and because the recordkeeping burden has been included in our estimate for batch production and control records. E:\FR\FM\20MRN1.SGM 20MRN1 17217 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices K. Distribution Records Sections 212.20(c) and 212.90(a) require that written procedures regarding distribution of PET drug products be established and maintained. We estimate that it will take approximately 1 hour annually to establish and maintain records of these procedures for each PET production facility. Section 212.90(b) requires that distribution records be maintained. We estimate that it will take approximately 15 minutes to create an actual distribution record for each batch of PET drug products, with a total burden of approximately 16,157 hours for all PET producers. L. Complaints Sections 212.20(c) and 212.100 require that PET drug producers establish written procedures for dealing with complaints, as well as document how each complaint is handled. We estimate that establishing and maintaining written procedures for complaints will take approximately 1 hour annually for each PET production facility and that each facility will receive approximately one complaint a year and will spend approximately 30 minutes recording how the complaint was dealt with. TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records 212.20(c) and (e); 212.50(a) and (b) ..................................... 212.20(d) and (e); 212.50(c); 212.80(c) ................................. 129 129 1.71 501 221 64,629 212.20(c); 212.30(b); 212.50(d), 212.60(f) ............................. 212.30(b); 212.50(d); 212.60(f) .............................................. 129 129 15 3,758 1,935 484,782 212.20(c); 212.40(a) and (b) .................................................. 212.40(e) ................................................................................ 129 129 2 36 258 4,644 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d). 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3) ....................... 129 25 3,225 129 501 64,629 212.70(f) ................................................................................. 212.20(c); 212.71(a) ............................................................... 212.71(b) ................................................................................ 212.20(c); 212.71(d) ............................................................... 212.20(c); 212.90(a) ............................................................... 212.90(b) ................................................................................ 129 129 129 129 129 129 1 36 1 1 1 501 129 4,644 129 129 129 64,629 212.20(c); 212.100(a) ............................................................. 212.100(b) and (c) .................................................................. 129 129 1 1 129 129 Total ................................................................................ ........................ ........................ ........................ 1 There Average burden per recordkeeper 20 ................ .5 ................. (30 min.) 1 .................. .08 ............... (5 min.) 1 .................. .166 ............. (10 min.) 1 .................. Total hours 4,420 32,315 1,935 40,237 258 771 3,225 .16 ............... (10 min.) 1 .................. 1 .................. 1 .................. 1 .................. 1 .................. .25 ............... (15 min.) 1 .................. .5 ................. (30 min.) 10,728 ..................... 115,400 129 4,644 129 129 129 16,157 129 65 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 21 CFR Section Number of respondents Annual frequency of disclosure Total annual disclosures Hours per disclosure Total hours 212.70(e) .............................................................................. 129 .25 32 1 32 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06351 Filed 3–19–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration srobinson on DSK4SPTVN1PROD with NOTICES BILLING CODE 4160–01–P Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: Notice. SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the E:\FR\FM\20MRN1.SGM 20MRN1

Agencies

[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17215-17217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06351]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0242]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Current Good Manufacturing Practice for Positron 
Emission Tomography Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
contained in FDA's regulations on current good manufacturing practice 
(CGMP) for positron emission tomography (PET) drugs.

DATES: Submit either electronic or written comments on the collection 
of information by May 20, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 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, including 
each proposed extension of an existing 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.

Current Good Manufacturing Practice for Positron Emission Tomography 
Drugs--(OMB Control Number 0910-0667)--Extension

    Positron emission tomography is a medical imaging modality 
involving the use of a unique type of radiopharmaceutical drug product. 
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that 
PET drug products meet the requirements of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) regarding safety, identity, strength, 
quality, and purity. The CGMP requirements for PET drugs are issued 
under the provisions of the Food and Drug Administration Modernization 
Act (FDAMA). These CGMP requirements are designed to take into account 
the unique characteristics of PET drugs, including their short half-
lives and the fact that most PET drugs are produced at locations that 
are very close to the patients to whom the drugs are administered.
    The CGMP regulations are intended to ensure that approved PET drugs 
meet the requirements of the FD&C Act as to safety, identity, strength, 
quality, and purity. The regulations address the following matters: 
Personnel and resources; quality assurance; facilities and equipment; 
control of components, in-process materials, and finished products; 
production and process controls; laboratory controls; acceptance

[[Page 17216]]

criteria; labeling and packaging controls; distribution controls; 
complaint handling; and recordkeeping.
    The CGMP regulations establish several recordkeeping requirements 
and a third-party disclosure requirement for the production of PET 
drugs. In making our estimates of the time spent in complying with 
these information collection requirements, we relied on communications 
we have had with PET producers, visits by our staff to PET facilities, 
and our familiarity with both PET and general pharmaceutical 
manufacturing practices. The estimated annual recordkeeping and third-
party disclosure burden is based on there being approximately 129 PET 
drug production facilities. Table 1 provides an estimate of the annual 
recordkeeping burdens. Table 2 provides an estimate of the annual 
third-party disclosure burdens associated with this collection.

A. Investigational and Research PET Drugs

    Section 212.5(b)(2) provides that for investigational PET drugs 
produced under an investigational new drug (IND) and research PET drugs 
produced with approval of a Radioactive Drug Research Committee (RDRC), 
the requirement under the FD&C Act to follow current good manufacturing 
practice is met by complying with the regulations in part 212 or with 
USP 32 Chapter 823. We believe that PET production facilities producing 
drugs under INDs and RDRCs are currently substantially complying with 
the recordkeeping requirements of USP 32 Chapter 823 (see section 
121(b) of the FDAMA), and accordingly, we do not estimate any 
recordkeeping burden for this provision.

B. Batch Production and Control Records

    Sections 212.20(c) through (e), 212.50(a) through (c), and 
212.80(c) set forth requirements for batch and production records as 
well as written control records. We estimate that it would take 
approximately 20 hours annually for each PET production facility to 
prepare and maintain written production and control procedures and to 
create and maintain master batch records for each PET drug produced. We 
also estimate that there will be a total of approximately 221 PET drugs 
produced, with a total recordkeeping burden of approximately 4,420 
hours. We estimate that it would take a PET production facility an 
average of 30 minutes to complete a batch record for each of 
approximately 501 batches. Our estimated burden for completing batch 
records is approximately 32,315 hours.

C. Equipment and Facilities Records

    Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain 
requirements for records dealing with equipment and physical 
facilities. We estimate that it would take approximately 1 hour to 
establish and maintain these records for each piece of equipment in 
each PET production facility. We estimate that the total burden for 
establishing procedures for these records would be approximately 1,935 
hours. We estimate that recording maintenance and cleaning information 
would take approximately 5 minutes a day for each piece of equipment, 
with a total recordkeeping burden of approximately 40,237 hours.

D. Records of Components, Containers, and Closures

    Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements 
on records regarding receiving and testing of components, containers, 
and closures. We estimate that the annual burden for establishing these 
records would be approximately 259 hours. We estimate that each 
facility would receive approximately 36 shipments annually and would 
spend approximately 10 minutes per shipment entering records. The 
annual burden for maintaining these records would be approximately 771 
hours.

E. Process Verification

    Section 212.50(f)(2) requires that any process verification 
activities and results be recorded. Because process verification is 
only required when results of the production of an entire batch are not 
fully verified through finished-product testing, we believe that 
process verification will be a very rare occurrence, and we do not 
estimate any recordkeeping burden for documenting process verification.

F. Laboratory Testing Records

    Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b), 
and 212.70(a), (b), and (d) set out requirements for documenting 
laboratory testing and specifications referred to in laboratory 
testing, including final release testing and stability testing. Each 
PET drug production facility will need to establish procedures and 
create forms for the different tests for each product they produce. We 
estimate that it will take each facility an average of 1 hour to 
establish procedures and create forms for one test. The estimated 
annual burden for establishing procedures and creating forms for these 
records is approximately 3,225 hours, and the annual burden for 
recording laboratory test results is approximately 10,728 hours.

G. Sterility Test Failure Notices

    Section 212.70(e) requires PET drug producers to notify all 
receiving facilities if a batch fails sterility tests. We believe that 
sterility test failures might occur in only 0.05 percent of the batches 
of PET drugs produced each year. Therefore, we have estimated in Table 
2 that each PET drug producer will need to provide approximately 0.25 
sterility test failure notice per year to receiving facilities. The 
notice would be provided using email or facsimile transmission and 
should take no more than 1 hour.

H. Conditional Final Releases

    Section 212.70(f) requires PET drug producers to document any 
conditional final releases of a product. We believe that conditional 
final releases will be fairly uncommon, but for purposes of the PRA, we 
estimated that each PET production facility would have one conditional 
final release a year and would spend approximately 1 hour documenting 
the release and notifying receiving facilities. The estimate of one 
conditional final release per year per facility is an appropriate 
average number because many facilities may have no conditional final 
releases while others might have only a few.

I. Out-of-Specification Investigations

    Sections 212.20(c) and 212.71(a) and (b) require PET drug producers 
to establish procedures for investigating products that do not conform 
to specifications and conduct these investigations as needed. We 
estimate that it will take approximately 1 hour annually to record and 
update these procedures for each PET production facility. We also 
estimate, for purposes of the PRA, that 36 out-of-specification 
investigations would be conducted at each facility each year and that 
it would take approximately 1 hour to document the investigation, which 
results in an annual burden of 4,644 hours.

J. Reprocessing Procedures

    Sections 212.20(c) and 212.71(d) require PET drug producers to 
establish and document procedures for reprocessing PET drugs. We 
estimate that it will take approximately 1 hour a year to document 
these procedures for each PET production facility. We do not estimate a 
separate burden for recording the actual reprocessing, both because we 
believe it would be an uncommon event and because the recordkeeping 
burden has been included in our estimate for batch production and 
control records.

[[Page 17217]]

K. Distribution Records

    Sections 212.20(c) and 212.90(a) require that written procedures 
regarding distribution of PET drug products be established and 
maintained. We estimate that it will take approximately 1 hour annually 
to establish and maintain records of these procedures for each PET 
production facility. Section 212.90(b) requires that distribution 
records be maintained. We estimate that it will take approximately 15 
minutes to create an actual distribution record for each batch of PET 
drug products, with a total burden of approximately 16,157 hours for 
all PET producers.

L. Complaints

    Sections 212.20(c) and 212.100 require that PET drug producers 
establish written procedures for dealing with complaints, as well as 
document how each complaint is handled. We estimate that establishing 
and maintaining written procedures for complaints will take 
approximately 1 hour annually for each PET production facility and that 
each facility will receive approximately one complaint a year and will 
spend approximately 30 minutes recording how the complaint was dealt 
with.

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
        21 CFR Section            Number of      records per    Total annual     Average burden     Total hours
                                recordkeepers   recordkeeper       records      per recordkeeper
----------------------------------------------------------------------------------------------------------------
212.20(c) and (e); 212.50(a)              129            1.71             221  20...............           4,420
 and (b).
212.20(d) and (e); 212.50(c);             129             501          64,629  .5...............          32,315
 212.80(c).                                                                    (30 min.)........
212.20(c); 212.30(b);                     129              15           1,935  1................           1,935
 212.50(d), 212.60(f).
212.30(b); 212.50(d);                     129           3,758         484,782  .08..............          40,237
 212.60(f).                                                                    (5 min.).........
212.20(c); 212.40(a) and (b).             129               2             258  1................             258
212.40(e)....................             129              36           4,644  .166.............             771
                                                                               (10 min.)........
212.20(c); 212.60(a) and (b);             129              25           3,225  1................           3,225
 212.61(a); 212.70(a), (b),
 and (d).
212.60(g); 212.61(b);                     129             501          64,629  .16..............          10,728
 212.70(d)(2) and (d)(3).                                                      (10 min.)........
212.70(f)....................             129               1             129  1................             129
212.20(c); 212.71(a).........             129              36           4,644  1................           4,644
212.71(b)....................             129               1             129  1................             129
212.20(c); 212.71(d).........             129               1             129  1................             129
212.20(c); 212.90(a).........             129               1             129  1................             129
212.90(b)....................             129             501          64,629  .25..............          16,157
                                                                               (15 min.)........
212.20(c); 212.100(a)........             129               1             129  1................             129
212.100(b) and (c)...........             129               1             129  .5...............              65
                                                                               (30 min.)........
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................         115,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                           21 CFR Section                               Number of       frequency of    Total  annual      Hours per       Total hours
                                                                       respondents       disclosure      disclosures       disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
212.70(e)..........................................................             129              .25               32                1               32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06351 Filed 3-19-13; 8:45 am]
BILLING CODE 4160-01-P