81 FR 36310 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 108 (June 6, 2016)

Page Range		36310-36312
FR Document		2016-13224

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 requirements relating to FDA regulations for human tissue intended for transplantation.

Federal Register, Volume 81 Issue 108 (Monday, June 6, 2016)

[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36310-36312]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13224]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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 
requirements relating to FDA regulations for human tissue intended for 
transplantation.

DATES: Submit either electronic or written comments on the collection 
of information by August 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to

[[Page 36311]]

the docket unchanged. Because your comment will be made public, you are 
solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0797 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Human Tissue Intended for 
Transplantation.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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.

Human Tissue Intended for Transplantation--21 CFR Part 1270 (OMB 
Control Number 0910-0302)--Extension

    Under section 361 of the Public Health Services Act (42 U.S.C. 
264), FDA issued regulations under part 1270 (21 CFR part 1270) to 
prevent the transmission of human immunodeficiency virus, hepatitis B, 
and hepatitis C, through the use of human tissue for transplantation. 
The regulations provide for inspection by FDA of persons and tissue 
establishments engaged in the recovery, screening, testing, processing, 
storage, or distribution of human tissue. These facilities are required 
to meet provisions intended to ensure appropriate screening and testing 
of human tissue donors and to ensure that records are kept documenting 
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures to be 
prepared and followed for the following steps: (1) All significant 
steps in the infectious disease testing process under Sec.  1270.21; 
(2) all significant steps for obtaining, reviewing, and assessing the 
relevant medical records of the donor as prescribed in Sec.  1270.21; 
(3) designating and identifying quarantined tissue; and (4) for 
prevention of infectious disease contamination or cross-contamination 
by tissue during processing. Sections 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

[[Page 36312]]

known, distribution, disposition, or expiration of the tissue, 
whichever is the latest. Section 1270.35(a) through (d) requires 
specific records to be maintained to document the following: (1) The 
results and interpretation of all required infectious disease tests; 
(2) information on the identity and relevant medical records of the 
donor; (3) the receipt and/or distribution of human tissue, and (4) the 
destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of 
human tissue intended for transplantation. Based on information from 
the Center for Biologics Evaluation and Research's (CBER's) database 
system, FDA estimates that there are approximately 383 tissue 
establishments of which 262 are conventional tissue banks and 121 are 
eye tissue banks. Based on information provided by industry, there are 
an estimated total of 2,141,960 conventional tissue products and 
130,987 eye tissue products distributed per year with an average of 25 
percent of the tissue discarded due to unsuitability for transplant. In 
addition, there are an estimated 29,799 deceased donors of conventional 
tissue and 70,027 deceased donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks 
(AATB) and Eye Bank Association of America (EBAA) adhere to standards 
of those organizations that are comparable to the recordkeeping 
requirements in part 1270. Based on information provided by CBER's 
database system, 90 percent of the conventional tissue banks are 
members of AATB (262 x 90% = 236), and 95 percent of eye tissue banks 
are members of EBAA (121 x 95% = 115). Therefore, recordkeeping by 
these 351 establishments (236 + 115 = 351) is excluded from the burden 
estimates as usual and customary business activities (5 CFR 
1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the 
remaining 32 establishments, which is 8.36 percent of all 
establishments (383 - 351 = 32, or 32/383 = 8.36%).
    FDA assumes that all current tissue establishments have developed 
written procedures in compliance with part 1270. Therefore, their 
information collection burden is for the general review and update of 
written procedures estimated to take an annual average of 24 hours, and 
for the recording and justifying of any deviations from the written 
procedures under Sec.  1270.31(a) and (b), estimated to take an annual 
average of 1 hour. The information collection burden for maintaining 
records concurrently with the performance of each significant screening 
and testing step and for retaining records for 10 years under Sec.  
1270.33(a), (f), and (h) include documenting the results and 
interpretation of all required infectious disease tests and results and 
the identity and relevant medical records of the donor required under 
Sec.  1270.35(a) and (b). Therefore, the burden under these provisions 
is calculated together in table 1 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.
    FDA estimates the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)                 32               1              32              24             768
 \2\............................
1270.31(a) and 1270.31(b) \3\...              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363             1.0         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036             1.0         380,036
1270.35(d)......................              32        1,454.50          47,504             1.0          47,504
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         626,735
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.


    Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13224 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P

36310 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices

5th Floor, Mail Room 5425, Washington, ESTIMATED REALLOTMENT AMOUNTS Evaluation and Research, Food and
DC 20201; telephone (202) 401–4870; OF FY 2015 LIHEAP FUNDS Drug Administration, 10903 New
email: lauren.christopher@acf.hhs.gov. Hampshire Ave., Bldg. 51, Rm. 6366,
FY 2015 Silver Spring, MD 20993–0002, 301–
SUPPLEMENTARY INFORMATION: It has been Grantee name reallotment 796–3601.
determined that approximately amount
$1,230,022 in LIHEAP funds may be SUPPLEMENTARY INFORMATION: In the
available for reallotment during FY Tennessee .................................. $271,910 Federal Register of Tuesday, October
2016. This determination is based on FY Puerto Rico ................................. 818,566 13, 2015, appearing on page 61426 in FR
2015 Carryover and Reallotment Reports Coyote Valley Band of Pomo In- Doc. 2015–25922, the following
dians ........................................ 9,025 correction is made:
that showed that seven grantees Eastern Shoshone Tribe ............. 37,413
reported reallotment funds (Tennessee, On page 61426, in table 1, the entries
Passmaquoddy Tribe at Pleas- for NDAs 016096 and 016097 are
Puerto Rico, Coyote Valley Band of ant Point .................................. 33,602
Pomo Indians, Eastern Shoshone Tribe, Poarch Band of Creek Indians ... 50,978 removed.
Passmaquoddy Tribe at Pleasant Point, The Klamath Tribes .................... 8,528 Dated: May 31, 2016.
Poarch Band of Creek Indians, and The Leslie Kux,
Total ..................................... 1,230,022
Klamath Tribes). Grantees submitted the Associate Commissioner for Policy.
FY 2015 Carryover and Reallotment [FR Doc. 2016–13182 Filed 6–3–16; 8:45 am]
Reports to the Office of Community Statutory Authority: 42 U.S.C. 8626.
BILLING CODE 4164–01–P
Services (OCS), as required by Mary M. Wayland,
regulations applicable to LIHEAP at 45 Senior Grants Policy Specialist, Division of
CFR 96.82. This amount, however, may Grants Policy, Office of Administration. DEPARTMENT OF HEALTH AND
increase because, as of April 1, 2016, the [FR Doc. 2016–13217 Filed 6–3–16; 8:45 am] HUMAN SERVICES
report for 68 grantees remains pending. BILLING CODE 4184–80–P
Food and Drug Administration
The statute allows grantees who have
funds unobligated at the end of the
DEPARTMENT OF HEALTH AND [Docket No. FDA–2013–N–0797]
federal fiscal year for which they are
awarded to request that they be allowed HUMAN SERVICES
Agency Information Collection
to carry over up to 10 percent of their Activities; Proposed Collection;
Food and Drug Administration
allotments to the next federal fiscal year. Comment Request; Human Tissue
Funds in excess of this amount must be [Docket No. FDA–2015–N–3432] Intended for Transplantation
returned to HHS and are subject to
reallotment under section 2607(b)(1) of Organon USA et al.; Withdrawal of AGENCY: Food and Drug Administration,
the Act (42 U.S.C. 8626(b)(1)). The Approval of 67 New Drug Applications HHS.
amount described in this notice was and 128 Abbreviated New Drug ACTION: Notice.
reported as unobligated FY 2015 funds Applications; Correction
in excess of the amount that these AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug
grantees could carry over to FY 2016. HHS. Administration (FDA) is announcing an
opportunity for public comment on the
OCS contacted each of the grantees to ACTION: Notice; correction.
proposed collection of certain
confirm that the FY 2015 funds information by the Agency. Under the
indicated in the chart may be reallotted. SUMMARY: The Food and Drug
Administration (FDA) is correcting a Paperwork Reduction Act of 1995 (the
In accordance with section 2607(b)(3) of PRA), Federal Agencies are required to
notice that appeared in the Federal
the Act (42 U.S.C. 8626(b)(3)), publish notice in the Federal Register
Register of October 13, 2015 (80 FR
comments will be accepted for a period concerning each proposed collection of
61426). The document announced the
of 30 days from the date of publication information, including each proposed
withdrawal of approval of 67 new drug
of this notice. extension of an existing collection of
applications (NDAs) and 128
After considering any comments abbreviated new drug applications from information, and to allow 60 days for
submitted, the Chief Executive Officers multiple applicants, effective November public comment in response to the
of LIHEAP grantees will be notified of 12, 2015. The document indicated that notice. This notice solicits comments on
the final reallotment amount. This FDA was withdrawing approval of the the information collection requirements
decision will be published in the following two NDAs after receiving a relating to FDA regulations for human
Federal Register. request from the NDA holder, Merck tissue intended for transplantation.
If funds are reallotted, they will be Sharp & Dohme Corp. (Merck), 1 Merck DATES: Submit either electronic or
allocated in accordance with section Dr., P.O. Box 100, Whitehouse Station, written comments on the collection of
2604 of the Act (42 U.S.C. 8623) and NJ 08889: NDA 016096, MINTEZOL information by August 5, 2016.
must be treated by LIHEAP grantees (thiabendazole) Tablets, and NDA ADDRESSES: You may submit comments
receiving them as an amount 016097, MINTEZOL (thiabendazole) as follows:
appropriated for FY 2016. As FY 2016 Oral Suspension. Before withdrawal of
funds, they will be subject to all these NDAs became effective, Merck Electronic Submissions
requirements of the Act, including informed FDA that it did not want Submit electronic comments in the
sradovich on DSK3TPTVN1PROD with NOTICES

section 2607(b)(2) (42 U.S.C. 8626(b)(2)), approval of the NDAs withdrawn. following way:
which requires that a grantee obligate at Because Merck timely requested that • Federal eRulemaking Portal: http://
least 90 percent of its total block grant approval of these NDAs not be www.regulations.gov. Follow the
allocation for a fiscal year by the end of withdrawn, the approval of NDAs instructions for submitting comments.
the fiscal year for which the funds are 016096 and 016097 is still in effect. Comments submitted electronically,
appropriated, that is, by September 30, FOR FURTHER INFORMATION CONTACT: including attachments, to http://www.
2016. Florine Purdie, Center for Drug regulations.gov will be posted to

VerDate Sep<11>2014 21:02 Jun 03, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\06JNN1.SGM 06JNN1

36312 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices

known, distribution, disposition, or there are an estimated 29,799 deceased collection burden is for the general
expiration of the tissue, whichever is donors of conventional tissue and review and update of written
the latest. Section 1270.35(a) through (d) 70,027 deceased donors of eye tissue procedures estimated to take an annual
requires specific records to be each year. average of 24 hours, and for the
maintained to document the following: Accredited members of the American recording and justifying of any
(1) The results and interpretation of all Association of Tissue Banks (AATB) deviations from the written procedures
required infectious disease tests; (2) and Eye Bank Association of America under § 1270.31(a) and (b), estimated to
information on the identity and relevant (EBAA) adhere to standards of those take an annual average of 1 hour. The
medical records of the donor; (3) the organizations that are comparable to the information collection burden for
receipt and/or distribution of human recordkeeping requirements in part maintaining records concurrently with
tissue, and (4) the destruction or other 1270. Based on information provided by the performance of each significant
disposition of human tissue. CBER’s database system, 90 percent of screening and testing step and for
Respondents to this collection of the conventional tissue banks are retaining records for 10 years under
information are manufacturers of human members of AATB (262 × 90% = 236), § 1270.33(a), (f), and (h) include
tissue intended for transplantation. and 95 percent of eye tissue banks are
documenting the results and
Based on information from the Center members of EBAA (121 × 95% = 115).
interpretation of all required infectious
for Biologics Evaluation and Research’s Therefore, recordkeeping by these 351
disease tests and results and the identity
(CBER’s) database system, FDA establishments (236 + 115 = 351) is
and relevant medical records of the
estimates that there are approximately excluded from the burden estimates as
383 tissue establishments of which 262 donor required under § 1270.35(a) and
usual and customary business activities
are conventional tissue banks and 121 (b). Therefore, the burden under these
(5 CFR 1320.3(b)(2)). The recordkeeping
are eye tissue banks. Based on provisions is calculated together in table
burden, thus, is estimated for the
information provided by industry, there 1 of this document. The recordkeeping
remaining 32 establishments, which is
are an estimated total of 2,141,960 8.36 percent of all establishments (383 estimates for the number of total annual
conventional tissue products and ¥ 351 = 32, or 32/383 = 8.36%). records and hours per record are based
130,987 eye tissue products distributed FDA assumes that all current tissue on information provided by industry
per year with an average of 25 percent establishments have developed written and FDA experience.
of the tissue discarded due to procedures in compliance with part FDA estimates the burden of this
unsuitability for transplant. In addition, 1270. Therefore, their information information collection as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

1270.31(a), (b), (c), and (d) 2 ............................................... 32 1 32 24 768
1270.31(a) and 1270.31(b) 3 ................................................ 32 2 64 1 64
1270.33(a), (f), and (h), and 1270.35(a) and (b) ................. 32 6,198.84 198,363 1.0 198,363
1270.35(c) ............................................................................ 32 11,876.12 380,036 1.0 380,036
1270.35(d) ............................................................................ 32 1,454.50 47,504 1.0 47,504

Total .............................................................................. ........................ ........................ ........................ ........................ 626,735
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 Reviewand update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.

Dated: May 27, 2016. SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In 1984,
Leslie Kux, Administration (FDA or Agency) has Congress enacted the Drug Price
Associate Commissioner for Policy. determined that the drug products listed Competition and Patent Term
[FR Doc. 2016–13224 Filed 6–3–16; 8:45 am] in this document were not withdrawn Restoration Act of 1984 (Pub. L. 98–417)
BILLING CODE 4164–01–P from sale for reasons of safety or (the 1984 amendments), which
effectiveness. This determination means authorized the approval of duplicate
that FDA will not begin procedures to versions of drug products approved
DEPARTMENT OF HEALTH AND withdraw approval of abbreviated new under an ANDA procedure. ANDA
HUMAN SERVICES drug applications (ANDAs) that refer to applicants must, with certain
these drug products, and it will allow exceptions, show that the drug for
Food and Drug Administration FDA to continue to approve ANDAs that which they are seeking approval
[Docket No. FDA–2016–N–1284] refer to the products as long as they contains the same active ingredient in
meet relevant legal and regulatory the same strength and dosage form as
Determination That APRESOLINE requirements. the ‘‘listed drug,’’ which is a version of
(Hydralazine Hydrochloride) Injectable the drug that was previously approved.
sradovich on DSK3TPTVN1PROD with NOTICES

and Other Drug Products Were Not FOR FURTHER INFORMATION CONTACT: ANDA applicants do not have to repeat
Withdrawn From Sale for Reasons of Stacy Kane, Center for Drug Evaluation the extensive clinical testing otherwise
Safety or Effectiveness and Research, Food and Drug necessary to gain approval of a new
Administration, 10903 New Hampshire drug application (NDA).
AGENCY: Food and Drug Administration,
HHS. Ave., Bldg. 51, Rm. 6236, Silver Spring, The 1984 amendments include what
MD 20993–0002, 301–796–8363, is now section 505(j)(7) of the Federal
ACTION: Notice.
Stacy.Kane@fda.hhs.gov. Food, Drug, and Cosmetic Act (21 U.S.C.

VerDate Sep<11>2014 16:36 Jun 03, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\06JNN1.SGM 06JNN1

Document Created: 2016-06-04 00:16:50
Document Modified: 2016-06-04 00:16:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 5, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 36310

81 FR 36310 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 108 (June 6, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration