PPTA Comment

August 26, 2011
Reference No.: FDAA11015
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
SUBJECT:

VIA WEB

Agency Information Collection Activities; Proposed Collection; Comment
Request; FDA Recall Regulations [Docket No. FDA-2011-N-0439]

Dear Sir or Madam:
The Plasma Protein Therapeutics Association (PPTA) is the international trade
association and standards-setting organization for the world’s major collectors of Source
Plasma and manufacturers of plasma derived products and recombinant analogues,
collectively referred to as plasma protein therapies, which are used in the treatment of a
number of rare diseases. The diseases are often genetic, chronic, life-threatening
conditions that require patients to receive regular infusions or injections of plasma
protein therapies for the duration of their lives. The therapies include clotting-factor
therapies for individuals with hemophilia A and B and other bleeding disorders;
immunoglobulins to treat a complex of diseases in individuals with immune deficiencies;
therapies for individuals who have alpha-1 anti-trypsin deficiency, which typically
manifests as adult onset emphysema and limits substantially life expectancy; and
albumin, which is used in emergency-room settings to treat individuals with shock,
trauma, burns, and other conditions. PPTA members are committed to assuring the
safety and availability of these medically needed, life-sustaining therapies.
PPTA is pleased to provide these comments on the reporting requirements on FDA
recalls.1 PPTA’s comments focus on
(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.2

1
2

See Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices, pp. 38184-86
See id. at 38185

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In general, PPTA member data are higher than FDA’s estimates of the burden of the
proposed collection of information; thus, FDA’s estimates appear low. For example, a
member estimated the average burden per response (ABPR) for firm initiated recall and
recall communications (§§ 7.46 and 7.49) is 60 (double FDA’s estimate of 30)3 and the
ABPR for recall status reports and followup (§ 7.53) is 20 (double FDA’s estimate of
10).4
However, PPTA notes that, in addition to the ABPR, data ranges are not given.5 As
stated, PPTA members manufacture plasma protein therapies, which comprise a small
portion of the drug market. PPTA recognizes that “[v]ariables in the type of products, the
quantity and level of distribution and the various circumstances of recall notifications
could cause the hours per response to vary significantly”6 and that FDA utilized “[t]he
best guesstimate of average burden hours per response from previous information
collection request reports.”7 However, without data ranges in FDA’s estimates, PPTA is
unable to assess if relatively high member data fall within the range of previously
collected information or are outliers. Thus, PPTA encourages FDA to provide data
ranges for industry to assess better the accuracy of the Agency’s estimates.
PPTA also suggests that an electronic tool for recall reporting, or eRecall tool, if it were
more effective and efficient for blood products than the manual system, could improve
the recall reporting process and, thus, both enhance the quality, utility, and clarity of the
information to be collected and minimize the burden of the collection of information on
respondents. However, PPTA cautions that such an eRecall tool would be useful only if
it were streamlined and it standardized the data requested; as such, industry should be
able to give input to any developer of user requirements for an eRecall tool before
implementation. In fact, for many biological product deviations (BPD), the current
electronic tool for BPD reporting is more difficult to use than the manual system
because of limitations in the software; thus, an ideal system would allow recall and BPD
databases to communicate and to populate automatically each other with information
that currently is provided multiple times to FDA. Today’s reporting requirements for
lookback, BPD, and recall are unduly burdensome for industry because they require
redundant and often untimely reporting.
In addition, PPTA assumes that FDA’s estimates include starting material (Source
Plasma) recalls. However, though FDA’s reporting requirements on recalls are
applicable to “any … biologic intended for human use,”8 today, the entire recall process
for Source Plasma can be considered an undue burden that adds no value. The unique
requirement of the lookback for blood products makes the recall process completely
3

See id.
See id.
5
See id.
6
See id. at 38186
7
See id.
8
See 21 CFR § 7.3(f)
4

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redundant in that all required notifications are made to the consignee, FDA, and the
donor months before the Agency decides whether to classify a report as a recall. Thus,
PPTA suggests that the requirements should apply only to finished goods that are
consumable; such a scenario would minimize the burden of the collection of information
on respondents. PPTA recommends that FDA’s entire recall program, not just
information collection, be reviewed to determine if the program serves the purpose
originally intended to protect consumers and if the current program adds value in light of
newer practices, requirements and technologies. With current budgetary constraints
facing industry and government, regulatory programs must add value if maintained.
PPTA appreciates the opportunity to comment on the reporting requirements on FDA
recalls and looks forward to continued work with the Agency. PPTA welcomes from FDA
any questions regarding these comments and/or requests for additional information.
Thank you for your consideration.
Respectfully Submitted,

Mary Gustafson
Vice President, Global Regulatory Policy
Plasma Protein Therapeutics Association