0116 SSA CBER GMP and Lookback 2018 Ext

U.S. Food and Drug Administration
Current Good Manufacturing Practice (CGMP) and
Related Regulations for Blood and Blood Components;
and Requirements for Donation Testing,
Donor Notification, and “Lookback”
OMB Control No. 0910-0116
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations.
All blood and blood components introduced or delivered for introduction into interstate
commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C.
262(a)). Section 351(a) of the PHS Act requires that manufacturers of biological products,
which include blood and blood components intended for further manufacture into products, have
a license, issued upon a demonstration that the product is safe, pure, and potent and that the
manufacturing establishment meets all applicable standards, including those prescribed in the
FDA regulations designed to ensure the continued safety, purity, and potency of the product.
In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary
of Health and Human Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases from foreign countries into the
States or possessions, or from one State or possession into any other State or possession. Section
351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic (FD&C Act) also applies
to biological products. Blood and blood components for transfusion or for further manufacture
into products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C.
321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and
plasma establishments must comply with the substantive provisions and related regulatory
scheme of the FD&C Act.
To implement these statutory provisions, regulations have been codified at 21 CFR Part 606 –
Current Good Manufacturing Practice for Blood and Blood Components; 21 CFR Part 610 –
General Biological Products Standards; 21 CFR Part 630 – Requirements for Blood and Blood
Components Intended For Transfusion or For Further Manufacturing Use; and 21 CFR Part 640
– Additional Standards for Human Blood and Blood Products. The regulations establish quality
standard requirements applicable to blood and blood products including information collection
provisions. Accordingly, we request extension of OMB approval of the information collection
provisions found in the applicable regulations and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The CGMP regulations for human blood and blood components (Part 606) and related
regulations (Parts 610, 630, and 640) implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. The public health objective in testing

2
human blood donors for evidence of infection due to relevant transfusion-transmitted infections
and in notifying donors is to prevent the transmission of relevant transfusion-transmitted
infections. For example, the “lookback” requirements are intended to help ensure the continued
safety of the blood supply by providing necessary information to consignees of blood and blood
components and appropriate notification of recipients of transfusions that are at increased risk for
transmitting HIV or HCV infection.
Consistent with the regulations, records maintained shall be made readily available for
authorized inspection. FDA is authorized to inspect these records under section 704 of the
FD&C Act (21 U.S.C. 374) (and its enforcement section under section 301(f) of the FD&C Act
21 U.S.C. 331(f)). We use the information to help determine compliance with regulatory
requirements established to ensure the safety and efficacy of the covered products. The thirdparty disclosure requirements identify the various blood and blood components and important
properties of the product, demonstrate that the CGMP requirements have been met, and facilitate
the tracing of a product back to its original source. The reporting requirements inform FDA of
certain information that may require immediate corrective action.
FDA allows the use or shipment prior to test results of human blood or blood components under
two circumstances: appropriately documented medical emergency situations or for further
manufacturing use as approved in writing by FDA. Use or shipment prior to test results may
occur, provided the consignee is notified that test results are not available, the tests for evidence
of infection due to relevant transfusion-transmitted infections are performed as soon as possible
after release or shipment, and the results are provided promptly to the consignee. The
regulations require an establishment to document the emergency release or shipment of blood or
blood components prior to completion of testing. If the establishment ships blood or blood
components for further manufacturing use prior to completion of testing, the establishment must
obtain prior approval from FDA. In either instance, the establishment must complete testing as
soon as possible thereafter, and must notify the consignee of test results as soon as they are
available. Prior approval is necessary to help ensure that an establishment is following proper
procedures in shipping potentially infectious blood and blood components for further
manufacturing use. Without this information, FDA could not monitor industry procedures and
discharge its statutory responsibility for protecting the nation’s health.
The donor notification process is intended to prevent further donations from donors who have
been deferred for positive test results for markers of certain relevant transfusion-transmitted
infections as prescribed in § 610.41 or for failing to satisfy the donor eligibility criteria under §§
630.10 and 630.15 prior to collection. Deferred donors are informed of: (1) The reason for the
decision; (2) the types of donation that the donor should not donate in the future, if appropriate;
(3) the results of the tests for evidence of infection due to relevant transfusion-transmitted
infections that were the basis for deferral, if applicable; and (4) information concerning medical
follow-up and counseling. By having this information, the deferred donor may make informed
decisions as to his or her medical welfare.

3
3. Use of Improved Information Technology and Burden Reduction
The regulations do not prescribe specific means by which respondents must fulfill the
information collection requirements. Establishments may use computers, computer discs, tapes,
microfiche, or microfilm in lieu of hard copy records for the purpose of maintaining records.
Computers may be used for emailing reports to FDA. Notification of consignees can be
accomplished by e-mail, phone, fax, or mail. There are no technical obstacles for electronic
reporting of the applicable information to FDA. FDA continues to pursue methods of applying
technology to reduce burden to the respondents of its information collection.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although OMB Control No. 0910-0795
(Requirements for Blood and Blood Components Intended for Transfusion or for Further
Manufacturing Use – Final Rule) was established to support amendments to the underlying
regulations (RIN 0910-AG87), we have submitted a request to discontinue that collection as the
information collection burden is now reflected here. Also, while GMP or quality system (QS)
regulations appear in several parts of Title 21 (Food and Drugs) of the CFR, this information
collection covers requirements applicable to blood and blood products as described under 21
CFR Parts 606, 630, and 640, and in this supporting statement.
5. Impact on Small Businesses or Other Small Entities
The public health protection requirements underlying the information collection apply to all
respondents; however, we believe they impose no undue burden on small entities. At the same
time, we assist small businesses in complying with agency requirements through our Regional
Small Business Representatives and through the scientific and administrative staffs within the
agency. We also provide a Small Business Guide on our website at
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and agency requirements
established to promote and protect the public health. There are no technical or legal obstacles to
reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of January 23, 2018 (83 FR 3165). One comment was received but was not
responsive to the four collection of information topics solicited and was therefore not addressed.

4

9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) and FDA’s published regulations of “Public Information” under 21 CFR
Part 20. After an FDA investigator completes a routine inspection of a blood or blood
component manufacturing establishment, the completed report with the results of the inspection
becomes public information, available under the FOIA. However, certain information, such as
donor and patient names, for example, is deleted from any information released by FDA under
the FOIA and FDA regulations. Manufacturers of human blood and blood components are not
required to reveal any proprietary information or trade secrets to achieve compliance with the
provisions.
11. Justification for Sensitive Questions
Establishments as part of the donation screening process for blood collection must ask questions
of a sensitive nature. These questions are used to evaluate the suitability of a donor. Donors not
meeting certain criteria are deferred from donating. This information is necessary to help
prevent the transmission of communicable diseases and protect public health. These records are
maintained by the establishment and may be reviewed by FDA during an inspection.
12. Estimates of Annualized Burden Hours and Costs
Respondents to the information collection are licensed and unlicensed blood establishments that
collect blood and blood components, including Source Plasma and Source Leukocytes, inspected
by FDA, and other transfusion services inspected by Centers for Medicare and Medicaid
Services (CMS). Based on information received from CBER’s database systems, there are
approximately 569 licensed Source Plasma establishments and approximately 1,054 licensed
blood collection establishments, for an estimated total of 1,623 (569+1,054) establishments.
Also, there are an estimated total of 680 unlicensed, registered blood collection establishments
for an approximate total of 2,303 collection establishments (569 + 1,054 + 680 = 2,303
establishments). Of these establishments, approximately 901 perform plateletpheresis and
leukopheresis. These establishments annually collect approximately 53.3 million units of Whole
Blood and blood components, including Source Plasma and Source Leukocytes, and are required
to follow FDA “lookback” procedures. In addition, there are another 4,961 establishments that
fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (formerly referred
to as facilities approved for Medicare reimbursement) that transfuse blood and blood
components.
The reporting, recordkeeping, and disclosure estimates are based on information provided by
industry, CMS, and FDA experience. Based on information received from industry, FDA
estimates that there are approximately 38.3 million donations of Source Plasma from

5
approximately 2 million donors and approximately 15 million donations of Whole Blood and
apheresis Red Blood Cells, including approximately 34,500 (approximately 0.23 percent of 15
million) autologous donations, from approximately 10.9 million donors. Assuming each
autologous donor makes an average of 1.1 donations, FDA estimates that there are
approximately 31,364 autologous donors (34,500 autologous/1.1 average donations).
FDA estimates that approximately 0.19 percent (21,000/10,794,000) of the 72,000 donations that
are donated specifically for the use of an identified recipient would be tested under the dedicated
donors testing provisions in § 610.40(c)(1)(ii).
Under § 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes, a licensed product that is used in the
manufacture of interferon, which requires rapid preparation from blood, is currently shipped
prior to completion of testing for evidence of infection due to relevant transfusion-transmitted
infections. Shipments of Source Leukocytes are approved under a biologics license application
and each shipment does not have to be reported to the Agency. Based on information from
CBER’s database system, FDA receives less than one application per year from manufacturers of
Source Leukocytes. However, for calculation purposes, FDA is estimating one application
annually.
According to CBER's database system, there are approximately 15 licensed manufacturers that
ship known reactive human blood or blood components under §§ 610.40(h)(2)(ii)(C) and (D).
FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood
components per month (12 per year) that would require two labels; one as reactive for the
appropriate screening test under § 610.40(h)(2)(ii)(C), and the other stating the exempted use
specifically approved by FDA under § 610.40(h)(2)(ii)(D).
Based on information FDA received from industry, FDA estimates that approximately 7,544
donations that test reactive by a screening test for syphilis, and are determined to be biological
false positives by additional testing annually. These units would be labeled accordingly
(§ 610.40(h)(2)(vi)).
Human blood or a blood component with a reactive screening test, as a component of a medical
device, is an integral part of the medical device, e.g., a positive control for an in vitro diagnostic
testing kit. It is usual and customary business practice for manufacturers to include on the
container label a warning statement that the product was manufactured from a donation found to
be reactive for the identified relevant transfusion-transmitted infection(s). In addition, on the
rare occasion when a human blood or blood component with a reactive screening test is the only
component available for a medical device that does not require a reactive component, then a
warning statement must be affixed to the medical device. To account for this rare occasion
under § 610.42(a), FDA estimates that the warning statement would be necessary no more than
once a year.
FDA estimates that approximately 3,021 repeat donors will test reactive on a screening test for
HIV. FDA also estimates that an average of three components was made from each donation.
Under § 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,063 (3,021 x 3) notifications of
the HIV screening test results to consignees by collecting establishments for the purpose of

6
quarantining affected blood and blood components, and another 9,063 (3,021 x 3) notifications to
consignees of subsequent test results. FDA estimates an average of 10 minutes per notification of
consignees.
FDA estimates that approximately 4,961 consignees will be required under § 610.46(b)(3) to
notify transfusion recipients, their legal representatives, or physicians of record an average of
0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors x
3) notifications. Also under § 610.46(b)(3), FDA estimates and include the time to gather test
results and records for each recipient and to accommodate multiple attempts to contact the
recipient.
Furthermore, FDA estimates that approximately 6,799 repeat donors per year would test reactive
for antibody to HCV. Under § 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments
would notify the consignee 2 times for each of the 20,397 (6,799 x 3 components) components
prepared from these donations, once for quarantine purposes and again with additional HCV test
results for a total of 40,794 (2 x 20,397 notifications) notifications as an annual ongoing burden.
Under § 610.47(b)(3), FDA estimate that approximately 4,961 consignees would notify
approximately 2,050 recipients or their physicians of record annually.
Based on industry estimates, roughly 14.3 percent of 9 million potential donors (1,287,000
donors) who come to donate annually are determined not to be eligible for donation prior to
collection because of failure to satisfy eligibility criteria. It is the usual and customary business
practice of approximately 1,734 (1,054+680) blood collecting establishments to notify onsite and
to explain why the donor is determined not to be suitable for donating. Based on such available
information, FDA estimates that two-thirds (1,156) of the 1,734 blood collecting establishments
provided on site additional information and counseling to a donor determined not to be eligible
for donation as usual and customary business practice. Consequently, FDA estimates that only
approximately one-third, or 578 of the 1,734, blood collection establishments would need to
provide, under § 630.40(a), additional information and counseling to the estimated 429,000 (onethird of approximately 1,287,000) ineligible donors.
It is estimated that another 4.5 percent of 10 million donors (450,000 donors) are deferred
annually based on test results. FDA estimates that approximately 95 percent of the
establishments that collect 99 percent of the blood and blood components notify donors who
have reactive test results for HIV, Hepatitis B Virus (HBV), HCV, Human T-Lymphotropic
Virus (HTLV), and syphilis as usual and customary business practice. Consequently, 5 percent
of the 1,623 establishments (81) collecting 1 percent (4,050) of the deferred donors (405,000)
would notify donors under § 630.40(a).
As part of usual and customary business practice, collecting establishments notify an autologous
donor’s referring physician of reactive test results obtained during the donation process required
under § 630.40(d)(1). However, FDA estimates that approximately 5 percent of the 1,054 blood
collection establishments (53) may not notify the referring physicians of the estimated 2 percent
of 31,364 autologous donors with reactive test results (627) as their usual and customary
business practice.

7
The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers,
which collect 99 percent of the blood supply, have developed SOPs as part of their customary
and usual business practice. Establishments may minimize burdens associated with CGMP and
related regulations by using model standards developed by industries’ accreditation
organizations. These accreditation organizations represent almost all registered blood
establishments.
Under § 606.160(b)(1)(x), FDA estimates the total annual records based on the 1,287,000 donors
determined not to be eligible to donate and each of the estimated 1,692,000 (1,287,000 +
405,000) donors deferred based on reactive test results for evidence of infection because of
relevant transfusion-transmitted infections. Under § 606.160(b)(1)(xi), only the 1,734 registered
blood establishments collect autologous donations and, therefore, are required to notify referring
physicians. FDA estimates that 4.5 percent of the 31,364 autologous donors (1,411) will be
deferred under § 610.41 which in turn will lead to the notification of their referring physicians.
Under § 610.41(b), FDA estimates that there would be 25 submissions for requalification of
donors. In addition, FDA estimates that there would be only 3 notifications for requalification of
donors under § 630.35(b). FDA also estimates the average time for each submission.
FDA permits the shipment of untested or incompletely tested but appropriately documented
human blood or blood components in rare medical emergencies and when appropriately
documented (§ 610.40(g)(1)). FDA estimates the recordkeeping under § 610.40(g)(1) to be
minimal with one or fewer occurrences per year. The reporting/disclosure of test results to the
consignee in § 610.40(g) does not create a new burden for respondents because it is the usual and
customary business practice of blood establishments.
The average burden per response (hours) and the average burden for recordkeeping (hours) are
based on estimates received from industry or FDA experience with similar recordkeeping or
reporting requirements.
The development of labels is a one-time burden. The container labels have been standardized
and are sold commercially. The label is only customized for the firm’s name and address. In
addition, the instruction circular is printed by major blood banking associations, the ARC,
AABB, and ABC, and are sold at minimal cost to the firms. The circulars are updated annually
usually due to new industry information. Therefore no burden is imposed by FDA regarding the
labeling and disclosure regulations (§§ 606.121 and 606.122) and Uniform Labeling of Blood
and Blood Components using ISBT 128 (Industry Consensus Standard for the Uniform Labeling
of Blood and Blood Components Using ISTB 128.
12a. Annualized Hour Burden
Based on this review, our estimate of the annual hourly burden associated with the
information collection is as follows:

8

21 CFR Section
606.170(b)2
610.40(g)(2)
610.41(b)
610.40(h)(2)(ii)(A)
630.35(b)
TOTAL

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of Responses per Total Annual
Respondents
Respondent
Responses
81
1
81
1
1
1
1,623
0.015
25
1
1
1
1,623
0.002
3
111

Average Burden
per Response
20
1
7
1
7

Total
Hours
1,620
1
175
1
21
1,818

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for §
606.170(b).
2 The

Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR
Section/Activity
606.100(b)2
606.100(c)
606.110(a)3

No. of
Recordkeepers
5
363
5
363
6
45

No. of Records
per Recordkeeper
1
10
1

Total Annual
Records
363
3,630
45

606.151(e)

5

12

4,356

606.1604

5

363

1,055.096

383,000

1,734

10.4533

18,126

4,961

3.6537

18,126

1,734

23.5259

40,794

4,961

8.2229

40,794

HIV recipient
notification
HCV recipient
notification
606.160(b)(1)(x)

4,961

0.3538

1,755

4,961

0.4132

2,050

2,303

734.6939

1,692,000

606.160(b)(1)(xi)

1,734

0.8137

1,411

606.160(b)(1)(viii)
HIV consignee
notification
606.160(b)(1)(viii)
HCV consignee
notification

363

606.165

5

1,055.096

383,000

606.170(a)
610.40(g)(1)

5

363
2,303

12
1

4,356
2,303

630.15(a)(1)(ii)(B)
630.20(c)
TOTAL

1,734
1,734

1
1

1,734
1,734
2,599,577

1 There

363

Average Burden
per Recordkeeping
24
1
0.5
(30 min)
0.08
(5 min.)
0.75
(45 min.)
0.17
(10 min.)
0.17
(10 min.)
0.17
(10 min.)
0.17
(10 min.)
0.17
(10 min.)
0.17
(10 min.)
0.05
(3 min.)
0.05
(3 min.)
0.08
(5 min.)
1
0.5
(30 min.)
1
1

Total
Hours
8,712
3,630
23
348
287,250
3,081
3,081
6,935
6,935
298
349
84,600
71
30,640
4,356
1,152
1,734
1,734
444,929

are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in §§ 606.171, 610.46(a) and (b), 610.47(a) and (b), 630.5(d), 630.10(c)(1) and (2), and 640.66,
which address the maintenance of SOPs, are included in the estimate for § 606.100(b).
3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis,
are included in the estimate for § 606.110(a).
4 The recordkeeping requirements in §§ 606.110(a)(2); 630.5(b)(1)(i); 630.109(f)(2) and (4); 630.10(g)(2)(i); 630.15(a)(1)(ii)(A)
and (B); 630.15(b)(2), (b)(7)(i) and (iii); 630.20(a) and (b); 640.21(e)(4); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b);
2 The

9
640.51(b); 640.53(b) and (c); 640.56(b) and (d); 630.15(b)(2); 640.65(b)(2)(i); 640.71(b)(1); 640.72; 640.73; and 640.76(a) and
(b), which address the maintenance of various records are included in the estimate for § 606.160.
5Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood
establishments (0.05 × 4,961 + 2,303 = 363).
6Five percent of plateletpheresis and leukopheresis establishments (0.05 × 901 = 45).

21 CFR Section
606.145(c)
606.170(a)
610.40(c)(1)(ii)
610.40(h)(2)(ii)(C)
and (h)(2)(ii)(D)
610.40(h)(2)(vi)
610.42(a)
610.46(a)(1)(ii)(B)
610.46(a)(3)
610.46(b)(3)
610.47(a)(1)(ii)(B)
610.47(a)(3)
610.47(b)(3)
630.40(a)3
630.40(a)4
630.40(d)(1)
TOTAL

Table 3.--Estimated Annual Third-Party Disclosure Burden1
No. of
No. of Disclosures
Total Annual Average Burden per
Respondents
per Respondent
Disclosures
Disclosure
4,961
0.2822
1,400
0.02
2
363
12
4,356
0.5
(30 min.)
2,303
0.0595
137
0.08
(5 min.)
15
12
180
0.20
(12 min.)
2,303
3.28
7,554
0.08
(5 min.)
1
1
1
1
1,734
5.2266
9,063
0.17
(10 min.)
1,734
5.2266
9,063
0.17
(10 min.)
4,961
0.3538
1,755
1
1,734
11.7630
20,397
0.17
(10 min.)
1,734
11.7630
20,397
0.17
(10 min.)
4,961
0.4132
2,050
1
578
742.214
429,000
0.08
(5 min.)
81
50
4,050
1.5
53
11.83
627
1
510,030

Total
Hours
28
2,178
11
36
604
1
1,541
1,541
1,755
3,467
3,467
2,050
34,320
6,075
627
57,701

1There

are no capital costs or operating and maintenance costs associated with this collection of information.
Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood
establishments (0.05 × 4,961 + 2,303 = 363).
3Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
4Notification of donors deferred based on reactive test results for evidence of infection due to relevant transfusion-transmitted
infections.
2

12b. Annualized Cost Burden Estimate
The estimated annual cost to respondents is $33,798,083.
Activity

Total Burden Hours

Hourly Wage Rate

Reporting

1,818

$67

Total Respondent
Cost
$121,806

Recordkeeping

444,930

$67

$29,810,310

Disclosure

57,701

$67

$3,865,967

Total

$33,798,083

10

The cost is based on a pay rate of $44/hour for a medical technologist (MT), who is responsible
for recording donor, quarantine, testing, and disposition of information, notifying consignees of
test results, and has the training and skills to handle various recordkeeping requirements. The
cost estimate is also based on a supervisor, at a pay rate of $59/hour who is responsible for
updating SOPs, recording donor information, and notifying physicians of recipients or recipients
of test results, investigating, writing, and reporting a fatality, and a Medical Director (MD), at a
pay rate of $97/hour, who is responsible for updating SOPs, recording donor information, and
notifying physicians of recipients or recipients of test results, investigating, writing, and
reporting a fatality. These salary estimates include recordkeeping, reporting, and disclosure
requirements that are performed by the MT, supervisor, or MD; the cost/hour includes the
average salary of the three ($67). These salary estimates include benefits but no overhead costs.
13. Estimates of Other Total Annual Cost Burden to Respondents and/or Recordkeepers/Capital
Costs
There are no capital or operating and maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
The estimated annualized cost to the Federal Government is $1,881,876. This estimate is based
on a FDA reviewer or investigator at an average grade scale of GS-12/5 ($56/hour), who reviews
the requests for approval submitted under §§ 610.40(g)(2) and 610.40(h)(2)(ii)(A), or performs
biannual on-site inspections. The inspection cost includes inspection of a facility, review of
facility records, and report preparation. The cost is based on 811 inspections, since the 1,623
facilities are inspected biannually. The estimated cost is also based on a GS-13/5 ($67/hour)
Consumer Safety Officer who compiles, reviews, and analyzes fatality reports. In Fiscal Year
2016, FDA received 81 fatality reports. These salary estimates include benefits but no overhead
costs.
Activity
Product Release Review
Inspection
Fatality Report Review
Total

Number of
Respondents
2
811
81

Number of
Hours
1
40
12

Cost per
Hour
$56
$56
$67

Total Cost
$112
$1,816,640
$65,124
$1,881,876

15. Explanation for Program Changes or Adjustments
The information collection reflects both changes as adjustments. As noted previously, we have
revised the collection to incorporate burden estimates previously accounted for under OMB
Control No. 0910-0795, which was established to support rulemaking (0910-AG87) that
amended the applicable regulations. At the same time, data suggests there are somewhat fewer
respondents to the collection than previously estimated and we have therefore adjusted the
number of respondents. Cumulatively this results in an overall decrease by 100,126 annual

11
responses and 5,725 burden hours. Finally, we have revised the IC list appearing at
www.reginfo.gov by consolidating the previously itemized regulatory provisions. We believe
this will assist the reader by more easily identifying the summary of cumulative fluctuations for
the collection. At the same time, readers may still view estimated burden associated with
individual provisions by referring to the agency’s 60-day and 30-day notices and in the burden
tables found in Question 12: Estimates of Annualized Burden Hours and Costs of this supporting
statement.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt display of the expiration date for OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.